REGULATORY STRATEGY CONSULTING
Registering a product in Singapore is a complex and challenging process. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for any successful product’s registration in Singapore.
Our regulatory team has the expertise in developing effective and tailored regulatory strategies for companies that helped them get their products successfully registered in Singapore, in timely manner and with minimal risk. By following our team recommended regulatory strategies, many foreign medical device companies could get access to Japanese medical market sooner than expected and exceed their business goals in Japan.
While developing the regulatory strategies, our local team takes perform the following tasks:
- Identify and the latest regulatory requirements related to your product.
- Proactively identify challenges or issues that may delay the approval of your product in Singapore
- 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 Singapore.
- Correctly identify the key success measures to obtain product reimbursement in Singapore.
The Singaporean medical regulatory system is generally industry-friendly. The government there, however, is currently trying to increase safety standards by expanding the range of medical products it reviews and approves.
The Guidance on Medicinal Product Registration in Singapore of 2009 describes the processes and procedures for registration of new drugs and variations and re-registrations.5 Alternative approaches may be accepted if supported by adequate scientific justification and agreed upon in advance with HSA. HSA also may request information not specified in the guidance if deemed necessary to assess the safety, efficacy and quality of the product under evaluation. HSA consistently seeks additional drug review assessment data from other agencies, such as the European Public Assessment Report (EPAR)
and US Food and Drug Administration (FDA) minutes of advisory committee meetings. It is important for the applicant to advise HSA if the application as submitted has been rejected, withdrawn or deferred by a regulatory authority in any country, and why.
|NDA1||For the first strength of a product containing a new3 chemical or biological entity|
|NDA2||(a) For the first strength of a product (i) containing a new combination of registered chemical or biological entities; (ii) containing registered chemical or biological entity(ies) in a new dosage form (e.g. tablets, capsules, injectables), new presentation (e.g. single-dose vials, multi-dose vials, pre-filled syringe) or new formulation (e.g. preservative-free); (iii) containing registered chemical or biological entity(ies) for use by a new route of administration; or, (iv) containing registered chemical or biological entity(ies) for new indication(s), dosage recommendation(s) and/or patient population(s). (b) For products that do not fall under the requirements for NDA-1, NDA-3 or GDA.|
|NDA3||For subsequent strength(s) of a product that has been registered or has been submitted as an NDA-1 or NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-1 or NDA-2.|
|GDA||Follow-on biologic products (also known as biosimilar products) are not eligible for a GDA and are required to be submitted via a NDA. GDA-1: For the first strength of a generic chemical product. GDA-2: For subsequent strength(s) of the generic chemical product that has been registered or submitted as GDA-1. The product name and dosage form should be the same as that for the GDA-1.|
|Full Route||Applies to any new product that has not been approved by any drug regulatory agency at the time of application submission to HSA.|
|Abridged Route||Applies to any new or generic product that has been evaluated and approved by at least one drug regulatory agency.|
|Verification Route||Applies to any new or generic product that has been evaluated and approved by HSA’s reference drug regulatory agencies, which include EMA, US FDA, Health Canada, TGA and UK MHRA.|
|Verification-CECA route||Applies to any generic product manufactured in India which has been evaluated and approved by HSA’s reference drug regulatory agencies, which include EMA, US FDA, Health Canada, TGA and UK MHRA.|
Step 1: Online application submission via PRISM
Step 2: Application Dossier (Should be submitted within 2 working days after application via PRISM)
Either the ICH CTD or the ACTD format is acceptable for making a submission to HSA.
|Documents||Location in ICH CTD||Location in ACTD|
|Administrative Documents and product information||Module 1||Part I|
|CTD Overview and summaries||Module 2||Incorporated in parts II, III and IV|
|Quality Documents||Module 3||Part II|
|Non-clinical documents||Module 4||Part III|
|Clinical Documents||Module 5||Part IV|
ISO 13485:2003 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 in Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries such as Japan, Korea, and Brazil.
Advantages of ISO 13485 certification
If you manufacture or market any Class II or higher risk classification device, and you sell it outside the US, most likely 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
Let us help you implement ISO 13485 or upgrade from ISO 9001
- With local offices located worldwide, our team of experienced QA consultants has helped hundreds of medical device and IVD manufacturers achieve ISO 13485 certification. We focus solely on medical device and IVD companies so we understand the unique needs and manufacturing scenarios of the industry. Here’s how we can help:We will fully customize your ISO 13485 quality system to meet your specific needs, and make sure you are ready for a certification audit.
- Our ISO 13485 consulting and project management teams will work closely with you to ensure that your QMS is implemented on time and on budget.
- We can recommend a number of qualified third-party testing and certification firms that specialize in your category of devices.
Medical devices and drugs in Singapore are regulated by the Health Sciences Authority (HSA) under the Singapore Ministry of Health (MOH). All medical devices and pharmaceutical products imported and/or sold in Singapore must be registered, regardless of risk class (except those exempted from registration). The licensing of dealers (manufacturers, importers, and wholesalers) is also mandatory.
LOCAL AUTHORIZED AGENT (REGISTRANT) FOR MEDICAL DEVICES
- Applications to the HSA can only be made via MEDICS (Medical Device Information and Communication System) e-Services. Thus, companies who wish to register their products with the HSA must appoint a local authorized agent who is registered with the ACRA (Accounting and Corporate Regulatory Authority) in order to register an account with the HSA.
LOCAL AUTHORIZED AGENT (REGISTRANT) FOR PHARMACEUTICALS
- Only a locally registered company can apply for a drug product license via PRISM (Pharmaceutical Regulatory Information System) and act as the product license holder, who is responsible for the safety, quality and efficacy of the product placed on the market.
- A medical device or drug company that does not have its own locally registered office in Singapore can appoint a locally registered company (either a distributor or an independent third party) to act as their local authorized agent and submit registration applications on their behalf.
- Dealers of medical device and pharmaceutical products must possess the appropriate dealer’s license depending on the activity they carry out in relation to the medical product – namely, manufacturer’s license, importer’s license, and/or wholesaler’s license.
- For medical devices, certification for Good Distribution Practice for Medical Devices (GDPMDS) is required in order to apply for an importer or wholesaler’s license.
- GRP can act as your Local Authorized Agent (Registrant) in Singapore. To find out more about the Singaporean medical regulations and local representation system, contact us for a free consultation with our expert regulatory consultants.
When registering new medical products in Asia, there are various reasons Western companies may want or need to conduct local clinical trials. The most common reason is that the local Asian government may require the clinical data for product registration. In addition, the large, genetically diverse population in Asia creates ideal sample populations, and the cost to perform clinical studies in Asia may be lower than in Western countries. In some cases, post market data may be required.
An understanding of the regulatory requirements in each Asian country and experience in dealing with the local regulatory authorities is essential in administering a smooth, successful clinical trial in Asia. Global Regulatory Partners (GRP) can act as your contract research organization (CRO) or help you identify a qualified Asian CRO. Our on-the-ground teams in Asia are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.
We offer the following services for medical device and pharmaceutical companies looking to conduct clinical trials in Asia:
- Clinical Trial Consulting Services
GRP will provide clinical trial consulting services, including consultations with all local Asian governments. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.
- Regulatory Support
We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in each Asian country. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate Asian regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.
- Clinical Trials Management
We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.
- Quality Compliance and Audits
We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.
- Adverse Events and Post Market Surveillance
We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.
Clinical trials that are conducted properly will facilitate a smooth registration approval process and expedite access to the Asian markets. If you need assistance with clinical trials for your medical product in Asia, contact us for a consultation with our Asia regulatory experts, or select your target market below for more information regarding clinical trials in each Asian country.