Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021

by Grace Wang Sep 30, 2021

Editor's Note: The monthly recap is a brief collection of recently-issued drug laws, regulations and policies in China, especially those issued by National Medical Products Administration (NMPA) and its affiliating office Center for Drug Evaluation (CDE).


1. NMPA Releases the 44th Batch of Reference Listed Drugs

On Aug. 16, NMPA published the 44th batch of reference listed drugs (RLD). The batch covers 54 drug products, such as N.V. Organon's Testosterone Undecanoate Soft Capsules and Pfizer's Tafamidis Meglumine Soft Capsules.

RLDs are selected by NMPA's generic drug quality and efficacy consistency evaluation expert panel. They are products to which new generic versions are compared to show that they are bioequivalent.

The English version of the 44th batch of RLDs has been uploaded to BaiPharm Database.


2. SAMR to Enforce New Rules for Medical Device and IVD Reagent Registration/Filing

On Aug. 26, China State Administration for Market Regulation (SAMR) promulgated Administrative Measures for Medical Device Registration and Filing and Administrative Measures for IVD Reagent Registration and Filing, both set to take effect on Oct. 1, 2021.

The two regulations specified the requirements for registration application/filing documentation, conditions for exempting clinical evaluation/trials, etc. For more details, please refer to ChemLinked BaiPharm article.

In this September, NMPA released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials, so that applicants can search in the lists to see if their products are eligible for exemption. For more details, please click here.


3. NMPA Announces Four Rx-to-OTC Switches

Grace Wang
ChemLinked Regulatory Analyst
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