NMPA Releases Guidance Document for Chemical Drugs/Biological Products

National Medical Products Administration(NMPA) of China releases two guidances on drug registration categories for Chemical Drugs / Biologic Products and Requirements for submission:-

a) 化学药品注册分类及申报资料要求 Classification System for Registration of Chemical Drugs and Requirements for submission dossier (No. 44 of 2020)
b) 生物制品注册分类及申报资料要求 Classification System for Registration of Biological Products and Requirements for submission dossier (No. 43 of 2020)

Both guidances are issued following the new requirements established in the Regulations on Drug Registration. The related circulars also specify the effective date and requirements for transitional period.

Chemical drugs are classified into the following 5 categories when applying for registration: innovative drug, new drugs due to improvement; generic drugs; drugs already marketed overseas but not registered in China.

Biological products are classified based on their functions into preventive category, therapeutic category and IVD reagents regulated as biologics.

The guidance gives specific explanations on the definition and applicable scope of each category, the requirements of registration, as well as the preparation of application dossier. In addition, the regional information for M4: CTD is attached after the guidance for biological products for further reference.

The classification systems for registration are effective on 1 July 2020; while the requirements for application dossier become effective on 1 October 2020.

In addition, the CDE has issued interim guidelines on the authority’s review and acceptance of chemical drugs and biological product registration applications.

For Chemical Drugs, the guideline includes two parts: Part I applies to drugs under category 1,2 and 5,1 according to registration classification system; Part I applies to drugs under category 3, 4, and 5,2. For biological products, the guideline includes three parts: Part I applies to preventive biological products (Vaccines); Part II applies to therapeutic biological products, and Part III applies to IVD reagents that are regulated as biologics. Each part is a separate guideline and gives specific explanations on the following aspects: basic requirements for application dossier; key considerations in application review; authority’s decision-making process and following steps; other relevant matters. A self-check list for application dossier as well as reference regulatory documents is also included as annexes.

Kindly refer to the link below for further information:-

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