Australia’s TGA
Medical Devices
The Therapeutic Goods Administration (TGA) is the unit of the Australian government’s Department of Health and Aging that oversees medical device regulation in Australia. Before selling any medical devices in Australia, they must first be registered in the Australian Register of Therapeutic Goods (ARTG).
The registering pathway for medical devices with the TGA depends on their risk classification compliance with quality, safety and performance principles; compliance with regulatory controls for manufacturing processes; listing in the Australian Register of Therapeutic Goods; and post-market vigilance programs.
TGA Medical Device Definition:
A medical device is defined as “any instrument, apparatus, implement, machine, appliance, implant, software, material or other similar or related device (including any diagnostic product for in vitro use) that is intended by the manufacturer to be used, alone or in combination, for human beings for the specific purpose of one or more of the following:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- investigation, replacement, modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception;
- disinfection of medical devices;
- providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
Software as Medical Device (SaMD):
An SaMD in Australia is defined as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In Vitro diagnostic Device (IVD)
An in vitro diagnostic medical device (IVD) is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.
More Resources:
- TGA website
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- To access more information click on the ‘ Read More‘ tab.
Authorized local agent
Medical device companies that don’t have a local presence in Australia, should appoint an Australian Sponsor. The Sponsor facilitates the device registration with TGA, acts as the liaison between the manufacturer and TGA, and the Sponsor’s name must appear on medical devices’ labeling.
Global regulatory partners, Inc. (GRP) can act as your local agent and provide you with the following medical/IVD services:
GRP Medical Device Services in Australia:
- Communication with the TGA
- Assistance with TGA inspections
- Adverse Effect Reporting
- Importation of products
- Organize and support TGA consultation meetings
- Product registration
- Clinical Trial management
- Support importation process
- Post-market vigilance
- Manage Distributors
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest TGA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Australia.
Regulatory Strategy
Defining the right regulatory strategy to be able to navigate through the regulatory system in Singapore is essential for successful product’s registration in Singapore. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in Australia, in timely manner and with minimal risk.
GRP medical device/ IVD regulatory strategy in Australia:
- Assess the Australian TGA registration requirements for your device(s).
- Research the proper GMDN codes for your medical device(s).
- Conduct a Technical File review to ensure completeness.
- Assistance with compilation or review of clinical summary (a TGA requirement).
- File documentation with the TGA.
- Assess compliance with other regulatory requirements (prerequisite for TGA approval).
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your medical product registered in Australia.
Regulatory Affairs
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Australia include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.
Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Australia in order to successfully register and commercialize their products in Australia’s market and maximize the value of their assets.
Product registration
| Device Class | Description | Examples |
|---|---|---|
| Class I | Low risk Medical Devices | Elastic bandages, tongue depressors, cervical collars, slings, non-sterile dressings |
| Class II a | Low-medium risk Medical Devices | X-ray films, intravenous tubing, contact lenses, catheters |
| Class II b | Medium-high risk Medical Devices | Blood bags, dressings for severe wounds, condoms |
| Class III | High risk | Coronary artery probes, intrauterine contraceptive devices, medical devices that contain medicines, such as dressings with an anti-microbial agent |
| Active implantable medical devices | High risk | Pace makers, cochlear implants |
The Australian TGA medical device registration process includes the following steps:
Step 1: Classification of the Medical Device
The determination of the classification of medical devices is performed according to Schedule 2 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. If a device has European CE marking, the classification will likely be the same. A CE Marking certificate from a Notified Body is generally accepted by the Therapeutic Goods Administration (TGA) as part of your registration.
Step 2: Appointment of Local Sponsor
Medical device companies that don’t have a local presence in Australia, should appoint an Australian Sponsor. The Sponsor facilitates the device registration with TGA, acts as the liaison between the manufacturer and TGA, and the Sponsor’s name must appear on medical devices’ labeling.
Step 3: Preparation of Technical File /Design Dossier/DC
The preparation of Technical File or Design Dossier (Class III) and Declaration of Conformity must be performed for submission. For all devices except Class I Non-sterile, non-measuring, Sponsor must submit Manufacturer’s Evidence (CE Marking certificate) in eBS system for TGA’s review and acceptance.
Step 4: Submission of the Medical Device Application in eBA System
For all classes, the Australian Sponsor submits Medical Device Application online in eBS system. The Application should include Intended Purpose statement, classification and GMDN code. Pay application fee.
Step 5: TGA Review of the Medical Device Application
The TGA will approve or reject your application. If approved by the TGA, an ARTG listing number will be issued (ARTG Certificate of Inclusion) and your listing will be included in the ARTG database on the TGA website.
Step 6: Medical Device Marketing
After the registration, medical devices can be marketed in Australia. The registrations do not expire, only if no changes are made to the device that would invalidate the ARTG listing, a current CE Marketing certificate (if applicable) is on file with the TGA, and the annual ARTG listing fee is paid.
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Australia. As Regulatory authorities, the TGA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health authority consultation
The TGA strongly recommends that applicants organize a pre-submission meeting for complex applications. Applicants will need to provide details in the PPF and the dossier (Module 1.8.1) of any meetings conducted with the TGTA. Such discussions should occur well in advance of PPF and dossier lodgment during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the TGA before starting key milestone of your product development. GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the TGA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Clinical
Conducting clinical trials in Australia is cost effective, and the data generated is well regarded internationally. GRP can help medical device/ IVD manufacturers assess the suitability of Australia as a site for conducting clinical trials for their drug. We provide assistance with researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in Australia and New Zealand.
GRP can help perform the following services for medical device and IVD companies in Australia:
- Assess qualification of clinicians, institutions and CROs
- Evaluate track record of clinicians and institutions for the type of devices to be investigated.
- Assist in creating awareness of manufacturer’s product with key clinicians and facilitate relationship between clinicians and manufacturer.
- Regulatory and product compliance requirements.
- Research IRB and Trial Indemnity requirements.
- CRO qualification and selection
- Thorough pre-qualification of Australian CRO based on needs.
- Intensive screening of CRO and level of experience, service level, etc. based on manufacturer’s criteria.
- Intensive one-on-one interviews to determine a “short list” of qualified candidates.
- Final selection is based on your comfort level and objectives.
- Manage Clinical Trials
- Liaison between your company and your appointed CRO in Australia.
- Assistance with troubleshooting.
- Contact and visit your Australian CRO to assess progress.
- Provide the manufacturer with independent reports on patient recruitment, trial progress and issues.
- Represent the manufacturer in any liaison activities with clinicians or institutions as required
Quality
Conformity assessment:
Conformity Assessment is the procedure used by TGA to determine whether the safety, quality and performance of a device are adequate. Depending on the risk classification of a device, there are different types of conformity assessment procedures that a manufacturer may select to use.
Evidence that an appropriate conformity assessment procedure has been applied must be provided for all devices (other than class I devices that are not sterile or do not have a measuring function) prior to their inclusion on the ARTG
Detailed information about conformity assessment and other aspects of medical device regulation is available in the Australian Regulatory Guidelines for Medical Devices.
ISO 13485:2016
ISO 13485:2016 is a quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies to meet the Quality Management System (QMS) medical device requirements serves as the basis for QMS compliance worldwide.
Advantages of ISO 13485 certification
If you manufacture or market medical devices you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:
- It is the “de facto” standard for global medical device QMS compliance for medical devices and is a prerequisite for access to most major markets worldwide.
- ISO 13485 certification requires effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
- Increased efficiency, better product quality and improved customer service within your company.
- Your commitment to quality will be evident to your consumers and partners
GRP ISO 13485 Services
- Customization of your ISO 13485 quality system to meet your specific needs,
- Training on ISO 13485 requirements
- Ensure that your QMS is implemented on time and on budget.
- Provide qualified recommendations for third-party testing and certification firms that specialize in your category of devices.
Pharmaceuticals
The Therapeutic Goods Administration (TGA) is the unit of the Australian government’s Department of Health and Aging that oversees pharmaceutical regulation in Australia. Before selling any pharmaceuticals in Australia, they must first be registered in the Australian Register of Therapeutic Goods (ARTG). Manufacturers must also provide Declarations of Conformity to the Australian Regulations to register with the TGA. Medicines in Australia are risk based and are divided into registered and listed medicines.
Registered Medicines Definition:
Registered medicines are higher risk. Because of this we fully assess all registered medicines for safety, quality and efficacy before they go on sale. Most Registered medicines are either categorized as over-the counter (OTC) or prescription Medicines. Prescription medicine are high risk and are only available to patients via a authorized health professional. OTC medicines are used mostly for mild health problems. Examples include headaches and sore throats.
Listed Medicine Definition:
Listed medicines are lower risk and can be purchased off the shelf from pharmacies, health shops, and supermarkets. Most listed medicines are categorized as a complementary medicine. Examples of complementary medicines are traditional herbal medicines and vitamins and minerals.
TGA Radiopharmaceuticals definition:
Radiopharmaceuticals contain a radioactive component or are intended to be combined with a radioactive component before use. They comprise of:
- ready-for-use radiopharmaceuticals, including Positron Emission Tomography (PET) radiopharmaceuticals
- nonradioactive components (kits and chemical precursors, including those for PET) for combination with a radioactive component (e.g. eluate from a radionuclide generator or a cyclotron-produced radionuclide)
- radionuclide generators
- radionuclide precursors used for radiolabelling other substances before administration.
More Resources:
- To access more information click on the ‘ Read More‘ tab.
- Australian Regulatory Guidelines for Prescription Medication.
- Australian Regulatory Guidelines for Biologics.
Authorized local agent
Pharmaceutical companies that don’t have a local presence in Australia, should appoint an Australian Sponsor. The Sponsor facilitates the device registration with TGA, acts as the liaison between the manufacturer and TGA, and the Sponsor’s name must appear on drug product’s labeling.
Global regulatory partners, Inc. (GRP) can act as your local agent and provide you with the following pharmaceutical services:
GRP Pharmaceutical Services in Australia:
- Communication with the TGA
- Assistance with TGA inspections
- Adverse Effect Reporting
- Importation of products
- Organize and support TGA consultation meetings
- Product registration
- Clinical Trial management
- Support importation process
- Post-market vigilance
- Manage Distributors
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.
At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence that includes the latest TGA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in Australia.
Regulatory Strategy
Defining the right regulatory strategy to be able to navigate through the regulatory system in Australia is essential for successful product’s registration in Australia. Global Regulatory Partners, Inc. (GRP) regulatory team has the expertise in developing effective and tailored regulatory strategies for medical device companies that helped them get their products successfully registered in Australia, in timely manner and with minimal risk.
GRP Pharmaceutical regulatory strategy in Australia:
- Assess the Australian TGA registration requirements for your product.
- Research the proper GMDN codes for your product.
- Conduct a Technical File review to ensure completeness.
- Assistance with compilation or review of clinical summary (a TGA requirement).
- File documentation with the TGA.
- Assess compliance with other regulatory requirements (prerequisite for TGA approval).
- Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
- Propose innovative solutions and approaches to circumvent these challenges ahead of time.
- Identify the most cost-effective way to get your drug product registered in Australia.
Regulatory Affairs
Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and registration till commercialization. GRP regulatory affairs services in Australia include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.
Our Regulatory affairs teams help pharmaceutical companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in Australia in order to successfully register and commercialize their products in Australia’s market and maximize the value of their assets.
Regulatory Operations
Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in China. GRP’s dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.
Global Regulatory Partners Inc. (GRP) Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management. GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements. GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.
Product registration
New Drugs:
The TGA does not have a classification for new drugs, but receives applications and fees as the following:
- New chemical entity
- New biological entity
- New fixed combination
- Extension of indications
Generic Drugs:
The Therapeutic Goods Regulations 1990, Regulation 2, defines a generic medicine as a medicine that:
a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine or previously registered medicine
b) has the same pharmaceutical form
c) is bioequivalent
d) has the same safety and efficacy properties
Biologics:
In Australia, ‘biologicals’ is the name for cell and tissue therapy products that;
- Comprise, contain or are derived from human cells or tissues, or
- Living animal cells, tissues and organs, and
- Are represented in any way to be for therapeutic use
There are three categories for application for prescription medicine in Australia described in the table below.
Table 1: Prescription Medicine Categories
| Category | Description |
|---|---|
| Category 1 |
• New chemical Entity • New indication for registered prescription product |
| Category 2 | Products which are previously approved in two acceptable countries |
| Category 3 | List of acceptable countries: US, Canada, Sweden, The Netherlands, United Kingdom Change to an already registered product. |
Registration Process: The regulatory process for evaluation of prescription medicines consists of eight phases. Table below summarizes the 8 milestones.
Table : Prescription Drug Registration Process
| Milestones of the various phases in the regulatory process | ||
|---|---|---|
| Phase | Relevant Milestone | |
| 1 – Pre-submission | MS1 | Outcome of pre-submission planning sent |
| 2 – Submission | MS2 | Outcome of application consideration sent |
| 3 – First round assessment | MS3 | 3 – First round assessment Outcome of first round assessment and section 31 request for information or documents sent |
| 4 – Consolidated section 31 request response | MS4 | End of section 31 request response period |
| 5 – Second round assessment | MS5 | Outcome of second round assessments sent |
| 6 – Expert advisory review | MS6 | Outcome of expert advisory committee review sent |
| 7 – Decision | MS7 | Decision made by delegate |
| 8 – Post-decision | MS8 | Administrative and regulatory activities complete |
Orphan drug designations:
An orphan drug is defined as a medicine, vaccine, or in vivo diagnostic agent that is: intended to treat, prevent, or diagnose a rare disease; or not commercially viable to supply to treat, prevent, or diagnose another disease or condition. The full definition of an orphan drug can be found in the Therapeutic Goods Regulations 1990 Section 16H.
For designated orphan drugs, the Secretary waives application and evaluation fees for the evaluation of a medicine for the purposes of registration.
Discussions with the TGA regarding orphan drug applications should commence well before the pre-submission phase. Applications for orphan drug designation should be lodged with the TGA two to three months before the intended start of the pre-submission phase. If an applicant has not received approval for the designation but chooses to proceed with the application, they become liable for the relevant application and evaluation fees.
Priority evaluations:
TGA now has a formal Priority review pathway for faster assessment of vital and life-saving prescription medicines (evaluation status to a Category 1 or 2 applications) for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. A valid Priority review designation must be held in order to access the Priority review pathway. Requests for priority evaluation should be discussed at a pre-submission meeting and will be considered in circumstances where:
- The active ingredient is a new chemical entity; and
- The medicine is indicated for the treatment or diagnosis of a serious, life threatening or severely debilitating disease or condition; and
- There is clinical evidence that the medicine may provide an important therapeutic gain.
- The allocation of priority evaluation status is not a guarantee that the total processing time of the application will be shortened, but the evaluation process will be performed as rapidly as possible.
Table 3: TGA Timelines for Prescription Drugs
| Category | Timeline (Working Days) |
|---|---|
| 1 | 255 |
| 2 | 175 |
| 3 | 45 |
| New chemical entities | 150 |
| New Generics | 100 |
| New Indications | 160 |
| New Indications | 30 |
| Additional trade names | 45 |
Medical writing
Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Australia. As Regulatory authorities, the TGA, expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.
Health Authority Consultation
The TGA strongly recommends that applicants organize a pre-submission meeting for complex applications. Applicants will need to provide details in the PPF and the dossier (Module 1.8.1) of any meetings conducted with the TGA. Such discussions should occur well in advance of PPF and dossier lodgment during the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.
Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the TGA before starting key milestone of your product development. GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the TGA health authority, prepare the questions based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Clinical
Conducting clinical trials in Australia is cost effective, and the data generated is well regarded internationally. GRP can help pharmaceutical manufacturers assess the suitability of Australia as a site for conducting clinical trials for their drug. We also provide assistance in researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in Australia and New Zealand.
Clinical trials conducted in Australia are subject to various regulatory controls to ensure the safety of participants.
Clinical trials of ‘unapproved’ therapeutic goods may be subject to Clinical Trials Notification (CTN) requirements, or Clinical Trials Exemption (CTX) requirements. Clinical trials that do not involve ‘unapproved’ therapeutic goods are not subject to these requirements. The therapeutic goods legislation requires that the use of therapeutic goods in a clinical trial conducted under the CTN/CTX schemes must be in accordance with:
- ICH Guidelines for Good Clinical Practice (GCP)
- National Statement on Ethical Conduct in Human Research (National Statement)
- The procedural protocol as approved by the Human Research Ethics Committee (HREC) responsible for monitoring the conduct of the trial.
The CTN Scheme (Approval Process):
TGA does not review/evaluate any data relating to clinical trials at the time of submission.
- All material relating to the proposed trial, including the trial protocol is submitted directly to the HREC for review and approval
- Supply of goods cannot commence without valid notification and payment of fee
- Each additional trial site needs to be notified to the TGA before commencing the trial at that site
The CTX Scheme ( Notification Process):
Designed for complex therapies – REQUIRED for certain Class 4 biologicals.
- Supply of goods cannot commence without HREC and TGA approval
– Primary responsibility of TGA is to review the safety of the product
– HREC responsible for considering the scientific and ethical issues of the proposed trial protocol - May conduct any number of clinical trials provided the use of the product falls within the approved usage guidelines
- Each trial must be notified to TGA
Legal Responsibilities:
- All trials under TGA regulation must have an Australian sponsor -initiates, organises and supports a clinical study and carries the medico-legal responsibility
- If there is a major protocol change to the protocol such that the ethics committees require a change to the conditions of their approval a new notification to the TGA may be required
- TGA has the authority to audit clinical trials on safety grounds and investigate non-compliance with either Good Clinical Practice guidelines or legislative requirements
- Sponsor responsible for reporting serious and unexpected adverse events during trials directly to TGA
– Clinical Investigators to report adverse events to both HREC and Sponsor
GRP Clinical Trial Services:
GRP can help perform the following services for Pharmaceutical companies in Australia:
Assess qualification of clinicians, institutions and CROs
- Evaluate track record of clinicians and institutions for the type of devices to be investigated.
- Assist in creating awareness of manufacturer’s product with key clinicians and facilitate relationship between clinicians and manufacturer.
- Regulatory and product compliance requirements.
- Research IRB and Trial Indemnity requirements.
CRO qualification and selection
- Thorough pre-qualification of Australian CRO based on needs.
- Intensive screening of CRO and level of experience, service level, etc. based on manufacturer’s criteria.
- Intensive one-on-one interviews to determine a “short list” of qualified candidates.
- Final selection is based on your comfort level and objectives.
Manage Clinical Trials
- Liaison between your company and your appointed CRO in Australia.
- Assistance with troubleshooting.
- Contact and visit your Australian CRO to assess progress.
- Provide the manufacturer with independent reports on patient recruitment, trial progress and issues.
- Represent the manufacturer in any liaison activities with clinicians or institutions as required
Quality
Pharmaceutical Quality Systems for Drugs Products:
Pharmaceutical companies are responsible for complying with TGA regulations to maintain a high level of safety, efficacy and quality of their products. Compliance can be achieved by implementing a pharmaceutical quality system. Adherence to the internal PQS can ensure the identity, strength, quality and purity of drug products by requiring stringent control of every step in the lifecycle. It is important to know CGMPs only are minimum (baseline) standards. A well-designed PQS should exceed these standards
Manufacturing Quality Branch (MQB):
MQB assesses the compliance of the folowing manufacturers:
- Prescription medicines*
- Over the counter medicines*
- Complementary medicines (herbal, traditional, vitamins)*
- Blood, tissues and cellular therapies^
against *Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Guide or ^Australian Manufacturing Standards through licensing, certification and clearance.
Legislative basis for Manufacturing Requirements:
The Therapeutic Goods Act 1989 sets out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. It details the requirements for listing, registering or including medicines, medical devices and biological products on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance.
- The Act aims to ensure the safety, quality, efficacy and timely supply of therapeutic goods for Australians.
- The Manufacturing Quality Branch operates several programs designed to ensure these aims are met.
Mutual Recognition Agreements:
- MRAs – treaties between Australia and other countries and are enforceable under international law
- Department of Foreign Affairs and Trade is involved in process of entering into an MRA. Decision made at a Government not a Departmental level.
- The parties to a MRA recognise and accept the certification issued by the relevant regulatory agency in each country in relation to manufacturers located within that country.
MRA Countries include:
- United kingdom
- Germany
- France
- Canada
Other arrangements:
- Cooperation agreements
- Memorandums of Understanding (MOUs)
- PIC/S membership –non-binding, informal, cooperative arrangement between the authorities that regulate GMP for medicinal products. Joint membership of PIC/S enables us in some circumstances, to assess evidence from regulators in member nations using the CV pathway where the inspection is undertaken in their own country and has occurred after the authority has ascended.
Other arrangements include:
- United States Food and Drug Administration (US FDA)
- European Directorate for the Quality of Medicines (EDQM)
- Members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S)
GMP Clearance:
All medicine manufacturers must receive approval from the TGA prior to manufacture and supply of products in Australia, unless exemptions or other provisions apply.
An approval demonstrates that the manufacturing site complies with the principles of GMP
- Australian manufacturers – GMP licence
- Overseas manufacturers – GMP clearance* to product sponsor of a medicine or Active Pharmaceutical Ingredients (API) if there is acceptable evidence demonstrating that the overseas manufacturer complies with the principles of GMP. Sponsors are required to obtain GMP clearance for overseas manufacturers of their registered or listed products to satisfy the legislative requirements.
Clearances are issued for specified time periods unlike domestic licences which are perpetual. Applications are lodged through the TGA business portal
GMP Inspection:
GRP’s Pharmaceutical quality assurance (QA) and regulatory affairs (RA) outsourcing services:
- Full consulting GMP quality assurance and regulatory affairs.
- Audits of your quality management system or a supplier’s quality system.
- Review of corrective actions and recommendations for resolution.
- Supporting quality metrics and analysis as part of the management review meetings.
- Internal auditor training, risk management, quality system, or other training needs.
- Complaint handling, contract review and surveillance audits.
- Document control and maintenance of the quality system.
Cosmetics
In Australia, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) regulates the importation and manufacture of chemicals for ‘industrial’ use, which includes cosmetics and soaps. Chemicals for human therapeutic use, such as medicines, are regulated by the Therapeutic Goods Administration (TGA). Ingredients in cosmetic products, even those described as ‘natural’, are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989, which is administered by the NICNAS.
Cosmetic Definition:
A cosmetic is defined as “A substance that is designed to be used on any external part of the human body—or inside the mouth—to change its odors, change its appearance, cleanse it, keep it in good condition, perfume it or protect it.”
Cosmetic or Therapeutic Good?
Some products are used in a similar way to cosmetics but are regulated as therapeutic goods, for example sunscreens. Several factors influence whether a product is a cosmetic or therapeutic good, including:
- the primary use or purpose of the product
- the ingredients in the product and their effects on the body
- how the product is applied and/or administered and
- how the product is promoted, represented, presented or labelled.
There is no single resource or government agency that provides all the information required when researching the cosmetic regulations in Australia, and no check list that covers all elements required to be on a cosmetic product label making the Australian Cosmetic markets complicated to navigate.
More Resources:
- To access more information click on the ‘ Read More‘ tab.
Authorized local agent
GRP’s team of professionals are experts in worldwide supply, registration, manufacturing and labeling of Cosmetics. GRP helps manufacturers, distributors, and marketers of cosmetics in Australia.
GRP Cosmetic Services (Australia):
- Regulatory intelligence
- Regulatory Strategy
- Regulatory affairs
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
Regulatory intelligence
GRP experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in the Australian market.
Regulatory Strategy
Developing the right regulatory strategy for your products in Australia crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. Our strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.
Regulatory Affairs
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with TGA regulatory authorities. Our Regulatory affairs teams help cosmetic companies understand and efficiently manage the demanding complexity of the Therapeutic Goods Administration (TGA) Regulatory requirements in order to successfully register and commercialize their products in Australia’s market.
Cosmetic packaging and labeling review
In Australia, All cosmetic products must be labelled in accordance with the mandatory standard for labelling of cosmetic products Global regulatory Partners, Inc. (GRP), provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate NICNAS regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with Australian requirements and the products can be used safely by the consumers. GRP can review your cosmetic packaging and labels to make sure it complies with NICNAS standards.
Product classification & Formulation Review
In Australia, ingredients in all cosmetic products are regulated as industrial chemicals under the Industrial Chemicals (Notification and Assessment) Act 1989, which is administered by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). To make sure that these products are safe for consumers, workers and the environment, the Australian Government assesses the risks associated with cosmetic products and/or ingredients manufactured or imported into Australia.
Cosmetic Ingredient Requirements:
- All ingredients in a cosmetic product must be listed on the Australian Inventory of Chemical Substances (the Inventory) or notified to NICNAS for pre-market assessment unless an exemption applies.
- All ingredients not on the Inventory and notified to NICNAS will be subject to public health, work health and safety (WHS), and environmental risk assessment.
- All ingredients not on the Inventory and introduced under an exemption from notification and some permit categories are subject to annual reporting and record keeping requirements.
Global Regulatory Partners Inc.(GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP can review your cosmetic classification and ingredient formulation to make sure it complies with TGA standards.
To find out if your product is a cosmetic regulated by NICNAS, please follow the process map provided by NICNAS.
Nutraceuticals
In Australia, medicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as ‘complementary medicines’ and are regulated as medicines under the Therapeutic Goods Act 1989 (the Act).
Complementary Medicine Definition:
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 or also known as ‘traditional’ or ‘alternative’ medicines, which include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
Complementary Medicine Categories:
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines. Complementary medicines may be either listed or registered, depending on their ingredients and the claims made. Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG); Higher risk medicines must be registered on the ARTG.
Complementary Medicine Definition:
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 or also known as ‘traditional’ or ‘alternative’ medicines, which include vitamin, mineral, herbal, aromatherapy and homoeopathic products.
Complementary Medicine Categories:
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines. Complementary medicines may be either listed or registered, depending on their ingredients and the claims made.
Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG);
Higher risk medicines must be registered on the ARTG.
Authorized local agent
Global Regulatory Partners, Inc, (GRP) has a team of experts who helps Nutraceutical and dietary supplements companies worldwide to register and commercialize their products in compliance with Therapeutic Good Administration (TGA) regulatory requirements in terms of labelling , packaging, nutrient content claims and health claims. GRP has local offices and strategic partners worldwide who can help you register and commercialize your complementary medicine in the Australian market.
GRP Nutraceutical Services (Australia):
- Authorized local agent
- Regulatory intelligence
- Regulatory strategy
- Regulatory affairs
- Product Registration
- Verification of Nutrient Content Claims
- Verification of Health Claims
Regulatory intelligence
Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization in Australia. GRP experts can collect the regulatory and other important requirements applicable from TGA to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Australia’s market.
Regulatory Strategy
Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for the Australian markets. GRP strategy will help you meet your business objectives and goals and reduce your risk of failure. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks.
With a global presence and a local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence.
Regulatory Affairs
TGA Pre-Market criteria of vitamins:
The TGA’s pre-market assessment of complementary vitamins and other low-risk medicines involves products meeting specific criteria:
- The product must only contain ingredients from a pre-approved list that the TGA has already assessed for safety and quality.
- The commercial sponsor of the product must choose from a pre-approved list of uses, and these uses can only relate to minor health problems. Products are prohibited from making claims about serious and life-threatening conditions.
- The product must be manufactured in a certified facility that meets quality standards.
- The sponsor of the product must hold evidence that their product does what they say it does.
GRP Regulatory Affairs Services:
Global regulatory Partner, Inc. (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Australia include regulatory intelligence, regulatory strategy, labelling , packaging, nutrient content claims and health claims. Our Regulatory affairs teams can help nutraceutical and dietary supplements companies understand and efficiently manage the demanding complexity of the Australian Regulatory requirements in order to successfully register and commercialize their products in the Australian market and maximize the value of their assets.
Verification of Nutrient Content Claims
Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. The marketing and advertising of therapeutic goods, including complementary medicines in Australia is regulated to be conducted in a manner that promotes the quality use of the product, is socially responsible and does not mislead or deceive the consumer.
The advertising of therapeutic goods in Australia is subject to the advertising requirements of the Therapeutic Goods Act, which adopts the Therapeutic Goods Advertising Code Act (TGAC) as well as other supporting Regulations such as the Trade Practices Act 1975 and other relevant laws.
In addition, the TGA regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.
List of Permitted Ingredient in medicines:
List of low risk ingredients that have been pre- approved by the TGA are included in the Permissible Ingredients Determination.
- Ingredients may have restrictions, such as:
- concentration limits
- route of administration
- plant parts
- type of preparation
- container type
- warning statements
List of Permitted indications:
An exhaustive list of all permitted indications and their requirements are contained in the Permissible Indications Determination No 1 of 2018 . The list of permitted indications will classify the category of the complementary medicine. The sponsor must hold evidence for all indications and claims at the time of listing and keep their evidence up-to-date.
For example, Listed medicines are can only refer to low level indications such as;
- health enhancement
- health maintenance
- prevention of dietary deficiency
- a disease, ailment, defect or injury other than a serious form of those diseases
Verification of Health Claims
Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. The marketing and advertising of therapeutic goods, including complementary medicines in Australia is regulated to be conducted in a manner that promotes the quality use of the product, is socially responsible and does not mislead or deceive the consumer.
The advertising of therapeutic goods in Australia is subject to the advertising requirements of the Therapeutic Goods Act, which adopts the Therapeutic Goods Advertising Code Act (TGAC) as well as other supporting Regulations such as the Trade Practices Act 1975 and other relevant laws.
Global Regulatory Partners Inc. (GRP), team has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements in Australia to make sure that they are supported by scientific data, are accurate and can be accepted by health authorities TGA.
Evidence For Listed Medicines :
The Sponsor must hold evidence for all indications and claims at the time of listing and keep their evidence up-to-date. The Guidelines on the evidence required to support indications for listed complementary medicines provide information for sponsors on:
- types of indications and appropriate evidence sources
- quality and credibility of evidence
- how to present evidence
A medicine can be cancelled from the ARTG if a sponsor is found to not hold evidence for their medicine’s indication and claims.
Product Registration
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines, including complementary medicines: Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG); Higher risk medicines must be registered on the ARTG.
In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality. Depending on the vitamin and the dose, vitamins are regulated either as prescription medicines or complementary medicines. Most vitamins fall into the category of low-risk complementary medicines. Unless exempt in the Therapeutic Goods Act of 1989, medicines sold in Australia must be included in the Australian Register of Therapeutic Goods (ARTG).
ARTG Registration:
All medicines that are approved for supply by the TGA include either an AUST R number or an AUST L number on their label.
- higher risk medicines are registered in the ARTG as AUST R. AUST R numbers are for registered medicines that the TGA has evaluated for safety, quality and efficacy.
- Lower risk medicines are listed in the ARTG – AUST L or AUST L(A). AUST L numbers are for low-risk listed medicines, such as most vitamin products, that the TGA regulates for safety and quality only.
Medicines that do not display these numbers may not be approved for sale in Australia. This is especially a concern for products sold online, which may contain unlisted, potentially dangerous ingredients.
Good Manufacturing Process:
All medicines, unless exempt, must be manufactured under the principles of GMP:
- Australian manufacturers must hold a GMP licence
- Overseas manufacturers must hold GMP clearance certificate
