NMPA Announcement on the Release of Revised Draft of the Appendix (Biological Products) as Recorded in the Good Manufacturing Practice for Drugs (Revised in 2010)
With the roll out of the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, NMPA has, in the light of Article 310 of the Good Manufacturing Practice for Drugs (Revised in 2010), revised the Appendix (Biological Products) (as a supporting document for the GMP), which has been released on April 26, 2020, and will come into force on July 1, 2020. Among them, in view of Article 59 of the Appendix, if an enterprise records data with an information system of real time data collection, given that information construction requires a certain period, it should meet the relevant requirements prior to July 1, 2022.
