Administrative Measures for Drug Post-marketing Changes for Trial Implemetaion Releasded by NMPA
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE：
January 12, 2021
EFFECTIVE DATE:
January 12, 2021
On January 12, 2021, the National Medical Products Administration promulgated the Administrative Measures for Drug Post-marketing Changes (for Trial Implemetaion) (“Administrative Measures”), which took effect on the same day.
One of the most crucial changes created by the Administrative Measures is the division of drug registration items into alterations for approval, alterations for filing and alterations for reporting, which shall be respectively implemented after going through the required procedures. Alterations requiring approval include, but are not limited to, alterations to the market authorization holders (MAHs) of domestically manufactured drugs and overseas manufactured drugs, whilst alterations for filing include changes to the names of MAHs, manufacturing enterprises and manufacturing sites of domestically manufactured drugs and imported drugs.
With regard to alterations to MAHs (for both domestically manufactured drugs and overseas manufactured drugs), the transferee of the marketing authorization shall apply to the Center for Drug Evaluation (CDE) for such alteration in the form of a supplementary application. The CDE will issue to the altered MAH a drug supplementary application notice, after approval of the alteration, instead of issuing a new drug registration certificate and withdrawing the original one. It is worth noting that the transferee of the marketing authorization by the MAH of domestically manufactured drugs shall first obtain a new drug manufacturing license with the relevant drugs being within the manufacturing scope before application.
Further, the Administrative Measures and its supporting documents specify the application path addressing the widespread concerned regarding the situation where overseas manufactured drugs that are marketed in Mainland China are transferred for domestic manufacturing. Domestic applicants may apply for drug regisrtation according to the registration classification of generic drugs and simultaneously submit original registration application materials for the overseas manufactured drugs (however, the specific application materials will be separately promulgated by the CDE). Additionally, if the overseas manufactured drugs are transferred to Mainland China for manufacturing through transfer of drug manufacturing technology, the domestic MAH may continue to conduct research and submit a supplementary application pursuant to the Notice on The Issuance of The Provisions for Registration of Drug Technology Transfer within a two-year transition period (before January 15, 2023). However, whether such transition period applies to other situations of transfer for domestic manufacturing except for transfer through drug manufacturing technology transfer is not clear.
Reference:
