China’s National Medical Product Administration (NMPA) has published on June 30,2020 new regulations on the registration of biologics in China. Changes to the registration of biologic include biologic being divided into three categories (preventative biologic, therapeutic biologic, and In-vitro diagnostic reagent products) and further division of a respective category into sub-categories. The regulation also outline requirements for the declaration of information that must be submitted to the NMPA according to product category.
Biologics are products derived from biotechnology to prevent, treat and diagnose human disease from microorganism, cells, animals or human-derived tissues and bodily fluids.
Preventive Biologic Products:
Preventive biological products are vaccine biologics, including immunization vaccines and non-immune-planned vaccines, for the prevention and control of disease and prevalence.
Preventative biologic are divided into three categories.
Category 1: Innovative vaccines: vaccines that are not available at home or abroad
Category 2: Improved vaccines: Improved vaccine products listed both domestically and overseas to improve the safety, effectiveness, quality control of new products and have significant advantages
Category 3: Domestic or overseas-listed vaccines
Therapeutic biological product:
Therapeutic biological products refer to biological products used in the treatment of human diseases, such as proteins, peptides and their derivatives prepared by engineered cells (such as bacteria, yeast, insects, plants and mammalian cells)
Category 1: Innovative biological products: domestic and foreign are not listed for therapeutic biological products.
Category 2: Improved biological products: domestic or overseas listed products to improve the safety, effectiveness, quality control of new products has improved, and has a clear advantage in the treatment of biological products.
Category 3: Domestic or overseas listed biological products
In-Vitro Diagnostic reagents:
In vitro diagnostic reagents managed by biological products include in vitro diagnostic reagents for blood source screening, in vitro diagnostic reagents labeled with radionuclides.
Category 1: Innovative in vitro diagnostic reagents.
Category 2: In vitro diagnostic reagents listed both inside and outside China.
NMPA biologic Registration:
Applicants need to submit all the Pharmaceutical Manufacturing reports and data, Clinical trial drug report and Non-Clinical reports for declaration of information in a CTD format. Specifications of these information is like the drug submissions.
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