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What is NPMA Registration in China?

China NMPA (National Medical Product Administration) Registration

The People's Republic of China is the fastest growing market for health and beauty products in the world and offers huge commercial potential for international manufacturers of medical devices, pharmaceuticals and cosmetics.

Entering the Chinese market can be challenging due to complex regulations, language barriers and intense competition. 

Cisema has handled hundreds of projects and can help you meet China's NMPA requirements. 


What is Chinese NMPA registration? 

It is the registration procedure of China's NMPA (National Medical Products Administration, formerly CFDA - China Food and Drug Administration), in which the following product categories are certified according to the guidelines:

 

Cosmetics

Medicines, pharmaceutical packaging and ingredients

 Medical devices (including IVDs)

Breast milk substitute

 Food for special medical purposes

Healthy food (food supplements and food products with special health functions)


In light of globalization, increasing international competition, and efforts to harmonize with other international standards, Chinese legislation introduced the approval of NMPA after opportunity identification into the system. 

Import, trade and use of the above products can only be done after obtaining a valid NMPA registration to ensure the quality and safety of the products.


What are the most important areas of responsibility of the State Pharmaceutical Administration?

(1) Safety supervision of drugs (including traditional Chinese medicine, ethnic medicine, same as below), medical device and cosmetics supervision. 

Develops regulatory policy plans, organizes the development of regulatory acts, develops regulatory documents and supervises their implementation. 

Research and formulation of foreign drugs, medical devices and cosmetics Monitoring and support policy for new technologies and new products. 

 

(2) Perform standard management of drugs, medical devices and cosmetics; organizes the compilation and issuance of "Chinese Pharmacopoeia" and other drug and medical device standards, organizes the preparation of cosmetic standards, organizes the formulation of classification management systems and supervises their implementation, participates in the creation of the national essential drugs list, assists in the implementation of the national essential drugs system. 


(3) Regulates the registration of medicines, medical devices and cosmetics. Formulate the registration system, strictly approve the list, improve the promotion of approval and organize the implementation. 


(4) Perform quality control of medicines, medical devices and cosmetics; formulates good laboratory practice (GLP) and good clinical practice (GCP) and monitors their implementation. 

Under the NMPA's duty to formulate good manufacturing practices (GMPs) and monitor their implementation, to develop good practices for the distribution and use of medical devices and to drive their implementation. 


(5) Taking care of post-marketing risk management of drugs, medical devices and cosmetics, organizes the monitoring, evaluation and management of side effects of drugs, adverse events of medical devices and adverse effects of cosmetic products.

In accordance with the law to act in emergency situations with medicines, medical equipment and cosmetics. 


(6) Engages in the administration of the qualification of licensed pharmacists, formulates regulations on the qualifications of licensed pharmacists and directs and supervises the registration of licensed pharmacists. 


(7) Organizes and directs the supervision and inspection of medicines, medical devices and cosmetics.

To establish an inspection system to investigate and deal with illegal activities in the registration process of drugs, medical devices and cosmetics, and to organize and lead the investigation and punishment of illegal activities in the production process in accordance with the duties of the Food and Drug Administration. 


(8) Carry out international exchange and cooperation in the supervision of medicines, medical devices and cosmetics and participate in the development of relevant international supervision rules and standards. 


(9) To direct the work of all drug control and administration departments of provinces, autonomous regions and municipalities directly under the central government. 


(10) To carry out other tasks assigned by the party's Central Committee and the State Council.

 

What are the regulations for NMPA registration in China? 

Not only for first-time applicants, but also for business veterans, changes in legislation and expanded legal requirements can lengthen the registration process. This is because the NMPA legislation for the approval of certain product groups has only recently been introduced and therefore needs to be constantly reassessed. 

Chinese NPMA organizational chart



What are NMPA Registration Management Rules?

 GB standard (national standard, "national standard" in Chinese) and

 YY Standard ("Industry Standard" from TCM-Traditional Chinese Medicine)

 

Similarities with international (EU, USA, etc.) standards. However, these guidelines have been supplemented with China-specific requirements. 

Previously achieved ISO standards may assist in the registration process, but are not required. 

Businesses can obtain more information about NMPA regulations and legal requirements by requesting our brochure. 


What is the Chinese State Food and Drug Administration?

Over the years, the structure and name of China's Life Science Product Regulatory Authority have changed several times. It is called SDA (State Drug Administration), SFDA (State Food and Drug Administration) and CFDA (China Food and Drug Administration).

China's State Food and Drug Administration (CFDA China, 国家药品监督管理局) renamed to National Medical Products Administration or NMPA China


On March 13, 2018, during the 13th National People's Congress, the Chinese Cabinet decided to rename CFDA to NMPA (National Medical Products Administration). 

During this conference, the number of ministerial departments was also reduced and SAMR (National Market Regulation Administration) was established to oversee NMPA, AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) and SAIC (National Market Regulation Administration). Business). 

The relevant regulations and the officials responsible for registration remain unchanged


On which date was CDFA replaced by NDMA?

On 1st September, 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association). 

China's State Food and Drug Administration (CFDA China, 国家药品监督管理局) renamed to National Medical Products Administration or NMPA China is Chinese government's administrative body responsible for regulating pharmaceuticals, medical devices and cosmetics in China.

 

Which Institutions are affiliated to NPMA China?

•  National Institutes for Food and Drug Control (Center for Medical Device Standards Management of NMPA, National Institute for Drug Control)

2019-07-19


•  Chinese Pharmacopoeia Commission

2019-07-19


•  Center for Drug Evaluation of NMPA

2019-07-19


•  Center for Food and Drug Inspection of NMPA

2019-07-19


•  Center for Drug Reevaluation of NMPA

2019-07-19


•  Center for Medical Device Evaluation of NMPA

 

•  Center for Administrative Services and Complaints & Reports of NMPA

2019-07-19


•  Information Center of NMPA

2019-07-19


•  NMPA Institute of Executive Development (NMPA Safety Emergency Drill Center)

2019-07-19


•  Certification Center for Licensed Pharmacist of NMPA

2019-07-19


•  News and Publicity Center of NMPA

2019-07-19


•  China Center for Food and Drug International Exchange

2019-07-19


•  Center for Administration Service of NMPA (Administration Service Bureau of NMPA)

2019-07-19


•  NMPA Southern Medicine Economic Research Institute

2019-07-19


•  146 Warehouse of NMPA

2019-07-19


•  Chinese Pharmaceutical Association

2019-07-19


•  China Health-Media Group

2019-07-19


Where can I get NPMA China registration form?

You may get NPMA China registration form from the link 


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