China’s DMF API License Renewal: Understanding NMPA’s Policy Update
Announcement No. 129 of 2023 was released by the National Medical Products Administration (NMPA) on October 13, 2023, focusing on the renewal of licenses for Active Pharmaceutical Ingredients …
NMPA - National Medical Products Administration
The revised Regulation aims to further encourage drug research and innovation, strengthen the whole life-cycle control of drugs and provide a solid legal guarantee for high-level drug safety and the high …
Changing of API registration in China NMPA- What you need to know
Jan 22, 2020 · Category I is the API which has already been used in listed final drug product in China, whether in domestic generics or importation drug. This category can be reviewed separately before …
Post-approval Changes to Active Pharmaceutical Ingredients (APIs ...
Dec 13, 2023 · For technical changes of APIs marked “A”, the API manufacturers should submit a change application in accordance with the relevant regulations on drug registration, and implement …
API Registration in China - Proregulations
Compared to the past when the final dosage form dossier was submitted with minimal API information required, pharmaceutical companies manufacturing outside of China are now required to submit a …
China Enforces Regulation on API Registration Renewal
Nov 30, 2017 · On Oct. 13, 2023, China NMPA implemented the Notice of the Administration of Active Pharmaceutical Ingredient (API) Registration Renewal, which applies to APIs that have obtained …
Regulations - NMPA
Good Clinical Practice for Medical Devices (Decree No. 25 of China Food and Drug Administration and National Health and Family Planning Commission of the People's Republic of China) (Abolished)
DMF Guide – China Drug Master File
China’s NMPA for Active Pharmaceutical Ingredient (APIs), Excipients and Packaging Materials introduced a NEW Drug Master File (DMF hereinafter) registration system since late 2017, reducing …
Provisions for Post-approval Changes of Drugs (Interim) - NMPA
Article 19 Where there is a change to the active drug ingredients that have passed the review and approval, the active drug ingredients registrant shall define the change management category in …
China NMPA Consults on Chemical API Registration Renewal Regulation
Nov 30, 2017 · For APIs manufactured in China, filers shall apply for renewal from the local provincial-level medical products administrations. For APIs manufactured overseas, filers shall submit the …