Pharmaceutical products (HS: 30)

Partial amendment to the Minimum Requirements for Biological Products

Partial amendment to the Public Notice on National Release Testing; (2 page(s), in English)

The Minimum Requirements for Biological Products will be amended as follows:

The standard for "Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)" that is to be newly approved will be added. And regarding the standard for "Recombinant Coronavirus (SARS-CoV-2) Vaccine", the article of "Virus seed lot" and "Virus-infected cell suspension" in the section of "Production control" will be partially amended. In addition, regarding the standard for "Inactivated Polio Vaccine", the article of "Potency test" in the section of "Tests on final product" will be partially amended．

The Public Notice on National Release Testing will be amended as follows: The criterion, fee, quantity and Institution for National Release Testing for "Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)" that is to be newly approved will be added. And the criterion, fee, and quantity for "Freeze-dried Recombinant Herpes Zoster Vaccine (Prepared from Chinese Hamster Ovary Cells)" and "Freeze-dried Smallpox Vaccine Prepared in Cell Culture" will be partially amended. In addition, the fee and quantity for "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Combined Vaccine" and "Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine" will be partially amended.