China’s National Medical Products Administration (NMPA)
Medical Device/IVD
Pharmaceuticals
Cosmetics
Food Supplements
Medical Devices
China’s Health Authority:
In China, Medical Devices are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA).
NMPA’s Medical Device Definition:
Medical devices are defines as instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly on the human body, including the required computer software; their utility is mainly obtained through physical methods, Not obtained through pharmacological, immunological or metabolic methods, or although these methods are involved but only play an auxiliary role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or relief of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Examination, substitution, adjustment or support of physiological structure or physiological process;
(4) Support or maintenance of life;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from the human body.
GRP Services:
Global Regulatory Partners Inc. (GRP), has offices in Shanghai and Beijing with teams of regulatory affairs, clinical, quality and pharmacovigilance experts who can collect the regularly intelligence develop the appropriate regulatory strategy and register successfully your medical device or IVD with the NMPA.
Authorized local agent
GRP China is licensed by NPMA to act as your Local Representative (RP) in China.
National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.
GRP- China Local Agent Services:
- Communicate with the NMPA
- Assist with NMPA inspection
- Adverse Effect Reporting
- Establishment registration and product listing
- Product registration
- Organize and support NMPA consultation meetings.
- Support importation process
- Provide support and manage product local testing
- Manage distributors
- License Renewal
Regulatory & Market Access Services
GRP Regulatory Affairs Services:
- Regulatory Intelligence (RI)
- Regulatory Strategy
- Regulatory Operations and Publishing
- Product Registration
- Products’ life cycle Management and Maintenance.
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.
Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in China’s market.
Most of the NMPA regulations are in Chinese and are changing continuously. Our regulatory team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China.
Our regulatory team in China makes sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in China.
We make sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in China.
Our regulatory team in China has many years of experience developing effective and tailored regulatory strategies for pharmaceutical companies that help them register successfully their drugs in China.
Device Market Access & Strategy Services:
- Device classification as per NMPA
- Assess Clinical Trial requirements and exemptions or CER
- In case of CER, evaluation of technical clinical information of a predictive/prototype CFDA approved device or review of existing clinical trial data standards.
- Technical document preparation and gap analysis
- Safety, quality and efficacy assessment
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. As Regulatory authorities expect precise, clear and well-written documents, any bad writing or badly translated documents can raise NMPA 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.
Product registration
Overview:
Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms. Device should be approved in original country before it is registered in China. Every medical device should be registered with NMPA for getting market access in China.
Medical Device Classification in China is based on Intended use, Structural Characteristics, form, operation, and Intended Use.
- Application form
- Safety and efficacy specification list
- Device Summary report
- Study report (product design, developed and verified report)
- Risk assessment report
- Product test reports
- Clinical evaluation documents
- Product technical documents(product standard documents)
- Manufacturing process explanation
- Self assurance statement
- Draft instructions and Labels
If you require assistance with obtaining approval for your medical device in China, at Global regulatory Partners Inc., (GRP) we can help you prepare the necessary documents and register your product with the Chinese Health Authority.
- Compilation of technical documents and registration application
- Dossier translation
- Clinical testing support and management
- Risk assessment, QMS audit and compliance
- Self assurance statement preparation
- IFU and Draft label preparation and translation
- Labelling and artwork compliance
- Local agent support, attend review meetings
- Liaison with HA until approval
- Import permit and custom support
- Monitoring and reporting adverse events
- Product recall
- HA query responses to regulatory and audits
- Quality management system (GMP and GSP compliance)
- Review of extrapolating studies
- Advertisement and promotional material regulatory compliance and approval
- License renewals and updates- technical document review and filing
Health authority consultation
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. GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.
GRP’s regulatory affairs team support includes:
- preparation and submission of the meeting package to the health authority,
- prepare the questions to health authority based on the status of your product’s development and future plan,
- provide support during the meeting,
- write the meeting minutes and develop the appropriate action plan after the consultation meeting.
Clinical
The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the NMPA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.
Medical Device clinical trials in China must comply with China’s GCP requirements. It is important to determine if the device requires the clinical trials. This can be decided based on the classification of the device.
As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.
After CDE CTA Review:
After the CDE’s review, a recommendation on whether to grant the applicant a Clinical Trial Permit (CTP) is submitted for confirmation to the NMPA. The CTP approval requires an extensive length of time—about 18 months after the initial CTA dossier is submitted to the NMPA. The NMPA prioritizes which clinical trial proposals to review first according to the product’s level of importance. Drugs that aim to cure serious diseases, such as AIDS and cancer, are normally fast tracked to get clinical trial approval.
After Obtaining a CTP:
After obtaining a CTP, the company is free to initiate clinical trials at any approved site in China, as long as they follow Good Clinical Practices (GCP) throughout the clinical trials.
- Class I
- Device Listed in Catalog of Medical device exempted from Clinical Trial
- Device comply with National or Industrial Standards
- CRO Oversight and Management
- Clinical Trial Application (CTA)
- Pre-clinical Investigation of Medical Devices
- Clinical Trial Protocol Design and Writing
- Clinical Trial Auditing and Quality Assurance
- Data Management and Statistical Analysis
- Clinical Studies Report Writing
GRP white Paper : Real World Evidence for Clinical Trials in china
On January 7th, 2020, NMPA published a new guideline on “Real-World Evidence that defines Real-World Data (RWD) and Real-World Evidence (RWE) terms and clarifies their use during drugs’ research and development and registration in China.
Quality
The NMPA has issued various regulations to strengthen management and organization at medical device manufacturing sites. This includes implementing Good Manufacturing Practice (GMP) standards for all medical devices, a more stringent adverse events and recalls system, additional on-site inspections, and other new industry standards. In addition to the NMPA, the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries out safety, certification, and inspection of certain medical devices to ensure adherence to quality standards.
However, despite the improving standards and implementation of GMP regulations for medical devices in China, there are still many scandals regarding defective products due to poor quality systems.
Foreign companies will need to conduct audits in order to ensure that their operations or partners in China are performing according to expected standards.
Required On-site Audits:
There are two types of on-site audits that are required in China:
- A one-time quality management system (QMS) audit for registration that domestic and foreign manufacturers must complete,
- A GMP audit for a manufacturing license after registration that local manufacturers must complete annually.
Requirements for these audits include an on-site audit checklist as well as multiple company meetings.
- In some factories in China, there are no organized or centralized quality manuals that employees can readily access. As a result, quality control in these factories may be minimal. Thorough audits can help locate the areas that are deficient and update the quality systems to meet Western standards.
- There may be poor document control and reporting inconsistency.
- if procedures change, the changes are usually not documented. When a device is reported as having failed, some factories do not investigate or report the adverse events. Having the factory audited can help identify post-market surveillance issues and set up systems for reporting adverse events.
- Even after a factory is GMP compliant and a good quality system is set in place, problems will still arise if employees are not invested in the process.
- It is essential that those employed by the medical device factory upkeep the maintenance required to guarantee an effective quality system. Many do not understand (or care about) the ramifications of poor-quality control or intellectual property theft.
- NMPA Audit preparation
- QMS implementation and monitoring compliance
- SOP writing and implementation
- Quality manual writing
- Ethics standard implementation and monitoring
- Ethical review of clinical protocol
- GxP Compliance
Pharmaceuticals
China’s Health Authority:
In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).
Drug Classifications:
- New Drugs, Class 1: innovative new drugs that have never been marketed anywhere in the world
- New Drugs, Class 2: improved new drugs that have never been marketed anywhere in the world
- Generic Drugs, Class 3: generic drugs, with equivalent quality and efficacy to the originator’s drugs, which are marketed in other countries, but not yet in China
- Generic Drugs, Class 4: generic drugs, with equivalent quality and efficacy to the originator’s drugs, that are already marketed in China
- Imported Drugs, Class 5: drugs that have been marketed in other countries, but not yet in China
Our local offices in Shanghai and Beijing in can act as your local authorized agent in different countries and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.
Market Access of Pharmaceuticals in China
GRP is licensed by NPMA to act as your Local Representative (RP) in China. National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.
- Communicate with the NMPA
- DFM Submission
- Assist with NMPA inspection
- Adverse Effect Reporting
- Establishment registration and product listing
- Product registration
- Organize and support NMPA consultation meetings.
- Support importation process
- Provide support and manage product local testing
- Manage distributors
- License Renewal
GRP China Local Representation for Foreign Manufacturers & Sponsors
GRP provides Local Agent Services in China to Globally leading Pharma & Medical Devices Manufacturers.
Regulatory Strategy
Our Regulatory Affairs department manages all regulatory matters for market access including all the services listed below.
GRP Regulatory Affairs Services:
- Regulatory Intelligence (RI)
- Regulatory Strategy
- Regulatory Operations and Publishing
- Product Registration
- Products’ life cycle Management and Maintenance.
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.
Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in China’s market.
The regulatory process from product design to market entry for a new drug is oftentimes complicated and unclear. Most of the NMPA regulations are in Chinese and are changing continuously. Our regulatory team stays current with the latest legislation, regulatory requirements and interpretations and industry initiatives in China.
Our regulatory team in China makes sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in China. We makes sure that our clients are kept informed of all changes that occur at the NMPA that may impact their regulatory and business strategies in China. Our regulatory team in China has many years of experience developing effective and tailored regulatory strategies for pharmaceutical companies that help them register successfully their drugs in China .
Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
- Proactively identify challenges or issues that may delay the approval of your pharmaceutical in China.
- 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 pharmaceutical product registered in China.
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.
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. As Regulatory authorities expect precise, clear and well-written documents, any bad writing or badly translated documents can raise NMPA 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.
Product registration
All drugs and drug substances (APIs) manufactured outside China must be registered via the imported drug application. Foreign-made APIs need to undergo a process like drug registration. Even if a product is approved elsewhere, the NMPA will most likely still require the foreign manufacturer to conduct at least some clinical testing in China before the drug is approved in China.
- New Drug
- Import Drug
- Generic Drugs
- Dietary Supplements
- Drug re-registration
The process of drugs registrations in China depends on the category they belong to. NMPA classifies drugs is three categories:
- Chemical
- Biological
- Traditional Chinese Medicine
In mid 2019, NMPA implemented a new process for pharmaceutical excipients registration in China, manufacturers have to register the DMF of their excipients using the CDE platform that generates automatically the DMF number.
Manufacturers of pharmaceutical excipients (excipients) should file their DMFs with required technical information to NMPA directly. Overseas manufacturers, with no presence in China, should authorize their domestic subsidiary or an agent to file their DMFs.Both manufacturers and their agents are responsible for the authenticity and integrity of the filed DMFs.
- Compilation of technical documents and registration application
- Dossier translation
- Clinical testing support and management
- Risk assessment, QMS audit and compliance
- Self-assurance statement preparation
- IFU and Draft label preparation and translation
- Labelling and artwork compliance
- Local agent support, attend review meetings
- Liaison with HA until approval
- Import permit and custom support
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.
GRP regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting. GRP regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets. For more information on health consultations check out our resource center or contact us.
GRP regulatory affairs team support includes:
- preparation and submission of the meeting package to the health authority,
- prepare the questions to health authority based on the status of your product’s development and future plan,
- provide support during the meeting,
- write the meeting minutes and develop the appropriate action plan after the consultation meeting.
WHITE PAPERS
Registration of DMF excipients in China
Manufacturers of pharmaceutical excipients (excipients) should file their DMFs with required technical information to NMPA directly.
Registration of DMF of Pharmaceutical packaging materials in China
Since, July 2019, NMPA requires manufacturers of Pharmaceutical Packaging Materials (PPM) to register the DMF using CDE platform.
CASE STUDIES
Clinical
As is the case in many countries around the world, a local clinical trial is almost always required for the registration of drugs in China. Since drug registration in China follows global International Conference on Harmonization (ICH) guidelines, data requirements in China are like those in the United States and other developed countries. However, companies may encounter difficulties if they want to keep sensitive data confidential from copying competitors.
In some cases, as an alternative to local clinical studies, a bioequivalence (BE) study will be required instead. The BE study will test similarities between two drugs believed to have the same active ingredients and use.
The NMPA’s Drug Regulatory Department oversees local clinical trials and affirms compliance with GCP. Generally, clinical trials in China involve four phases:
- Phase I – an initial review of the drug’s safety to humans
- Phase II – an evaluation of the effectiveness of the drug
- Phase III – a confirmation for the effectiveness of the drug
- Phase IV – a post-marketing study
The filing process for clinical trials in China begins with submitting a Clinical Trial Application (CTA) dossier to the NMPA. The Center for Drug Evaluation (CDE) reviews the submission dossier, test report, and verified specification, and requests a panel meeting if any concerns or questions are raised. The CDE may issue supplementary requests if any additional documents are needed from the applicant. The National Institute of Food and Drug Control (NIFDC) tests and analyzes the quality of the drug samples, while the Center of Food and Drug Inspection (CFDI) inspects sponsors and manufacturing sites.
An understanding of the regulatory requirements in China and experience in dealing with the NMPA is essential in administering a smooth, successful clinical trial in China. Global Regulatory Partners, Inc. (GRP) can act as your contract research organization (CRO) or help you identify a qualified CROs in China. Our local teams and affiliated partners located in China and all-around 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.
Clinical trials that are conducted properly in China will facilitate a smooth registration approval process and expedite access to other Asian markets. If you need assistance with clinical trials for your medical product in China, contact us for a consultation with our regulatory experts.
WHITE PAPERS
Overview of Clinical Trial application (CTA) in china
In China, a Clinical Trial Application (CTA) should be submitted to the National Medical Products Administration (NMPA), to request the authorization to administer an Investigational Drug to humans. CTA can be submitted to NMPA for Phase I through Phase IV clinical trials, including bioequivalence trials, that are conducted in China.
Real World Evidence for Clinical Trials in China
On January 7th, 2020, NMPA published a new guideline on “Real-World Evidence that defines Real-World Data (RWD) and Real-World Evidence (RWE) terms and clarifies their use during drugs’ research and development and registration in China.
CASE STUDIES
Case Study 029: Quality Audit and Preassessment before NMPA Inspection for a European CMO
The Client had network of 10+ manufacturing sites in 5 European locations with several development and distribution centers.
Cosmetics
China’s Health Authority:
In China Cosmetics are regulated by the National Medical Products Administration (NMPA). Before a cosmetic product is put on the market, the manufacturer must carry out a sanitary quality inspection of the product in accordance with the State’s “Cosmetic Hygiene Standards”, and products that pass the quality shall be marked with a pass mark. Products that have not been inspected or do not meet sanitary standards cannot be sold in China.
NMPA Definition of Cosmetics:
The regulation defines cosmetics as: “Products that can be spread on the outer surface of human body (e.g. skin, hairs, nails. lips etc.), the teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, deodorizing and keeping in good condition, by way of smearing, spraying or other similar means”.
NMPA Cosmetic Categories:
Cosmetic products are divided into two categories: Non-Special Use Cosmetics (Non-SUC) (such as hair care, skin care, nail products, and fragrances), and Special-Use Cosmetics (SUC) (such as hair regrowth products, deodorants and sunscreens). Cosmetics require different pre-market applications depending on their category.
Cosmetic Product Registration:
Foreign manufacturers that want to import cosmetics (SUC and Non-SUC) products into China need to assign an Authorized Local Agent who will be responsible in handling the products’ registration in the country.
National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China. China has two categories of cosmetics – non special use cosmetics (non-SUC) and special use cosmetics (SUC), and the approval process differs for the two categories. Non- SUC have to go through the pre-market filing process, and SUC are subject to pre-market registration. Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and import your cosmetics (SUC and Non-SUC) products into China.
Prohibited Cosmetic Ingredient List:
China regulates banned and restricted substances in cosmetic products similarly to EU Cosmetic regulation, which includes lists of prohibited and restricted substances, colorants, preservatives, and UV filters these lists are contained in the Hygienic Standard for Cosmetics 2007, the standard that all cosmetic products and ingredients must adhere to, which also contains methods of toxicological test, hygienic chemical test and microbiological test along with efficacy evaluation methods.
Cosmetics labels are subject to review by NMPA expert panel during registration and also checked by CIQs when products arrive at port. Product label and name: the applicant should concentrate on mandatory labeling items, warning statement, authentic Chinese translation of imported product label, appropriate efficacy claims and the correct SPF identification.
According to Instruction for Use of Consumer Products—General Labelling for Cosmetics (GB 5296.3-2008), the following information shall be indicated on labels of the imported cosmetics:
- Product name
- Name and address of manufacturer, distributor
- Country of origin
- Approval ID number (the ID number on the administrative license or record-filing certificate
- List of ingredient (all ingredients with concentration over 1.0% must be indicated with Chinese INCI names and listed in descending order of “quantity”; in absence of INCI name, the corresponding name in Chinese Pharmacopoeia, its chemical or botanical name can also be adopted)
- Net content
- Production date and shelf life or the batch number and expiration date
- Warnings (for products containing restricted substances)
- Instruction and storage condition
- Other info (the local distributor or wholesaler can be indicated as well)
Claims made by Cosmetic Products:
Manufacturers of cosmetic cannot claim functions or features that the products that are not truthful and backed on evidence. Medicinal or therapeutic function claims and any misleading wordings are prohibited.
Local expertise will be necessary regarding product compliance with China’s requirements. a Certain claims on some imported products, such as “hypoallergenic” or “dermatologically tested” will be challenged by the NMPA’s expert panel f not evidence is given.
Their are 2 possible options for labeling the of imported cosmetics.
- Company can design the label especially for the Chinese market according to Chinese labeling regulations
- Company can use the original package with a China compliant over-label.
In China cosmetic must be tested by NMPA approved labs even if they have been tested and assessed as “safe” abroad. Testing items and duration depend on the type and property of cosmetic products.
Testing takes around 2-4 months for non- SUC, and it may take a year or more for SUC, which require some additional testing. Testing reports have to be included in the product’s dossier. The latter is compiled by the RA or RP, depending on the process, and it includes documentation on the quality and safety of the product.
Animal Testing:
It is important to note that China still requires animal testing of cosmetics. All imported cosmetic products, as well as domestic SUC, have to be tested at the NMPA approved labs, which perform tests on animals
GRP- China Cosmetic Services:
- Authorized local Agent
- Regulatory Intelligence (RI)
- Regulatory Strategy
- Product Registration
- Cosmetic packaging and labeling review
- Product classification & Formulation Review
White Paper: Registration of Imported cosmetics in China
Foreign manufacturers of cosmetics interested in entering Chinese cosmetic market without a local subsidiary need to assign a Chinese Responsible Person (RP)*. The RP will be responsible for filing products, the import, management, and the product quality and safety of that product in the territory of China.
Video: Registration of Imported cosmetics in China
Do You Need Support for Cosmetic Registration in China? The RP will be responsible for filing products, the import, management, and the product quality and safety of that product in the territory of China.
Food Supplements
NMPA Dietary Supplement Categories:
There are currently two kinds of dietary supplements in China: functional food and nutrition supplements. Functional food must be registered before entering China’s market. As it can have different functions, such as enhancing immunity, helping the protection against radiation hazards, improving sleeping quality, increasing bone density, acting antioxidants, and improving memory. Nutrition supplements are generally used to supplement and correct deficiencies with the intake of certain vitamins and or minerals.
GRP Dietary supplement Services in China:
Global Regulatory Partners, Inc. (GRP) has a team of experts in China who can help Nutraceutical and food supplements companies in China during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations.
The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
More Resources:
- ‘Read More‘ To access more information on Nutraceuticals and GRP’s services in China.
Market Access for Food Supplements in China
National Medical Product Administration (NMPA) requires any foreign manufacturer who intends to register and sell its products in the People’s Republic of China to retain a local agent with a physical address in China.
In China supplements are regulated by Order No. 31 of the State Administration for Market Regulation. The registration, filing, supervision and management of health food within the territory of the People’s Republic of China are subject to these measures. (October 23, 2020). Supplements in China must be registered or notified by a local responsible person.
Global regulatory Partners, Inc. (GRP) has local offices in Beijing and Shanghai that are licensed by local authorities to act as your local agent and can help you register and commercialize your nutraceuticals (Functional food and nutrition supplements) in China
GRP- China Food Supplement Services:
- Local Representation
- Formula Assessment
- Label Compliance Review
- Product Classification
- Importation & management of local testing
- Product Registration with NMPA