Monthly Recap: China Pharmaceutical Regulatory Updates | July 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 the Center for Drug Evaluation (CDE).

1. NMPA Releases the 43rd Batch of Reference Listed Drugs

On July 23, after the deliberation and confirmation by the expert panel for consistency evaluation, NMPA released the 43rd batch of reference listed drugs (RLDs)¹, adding 39 drugs to the Catalog of RLDs in China. This batch includes Sanofi's Laxoberon and Roche's Dormicum. The RLDs are selected to assess the bioequivalence of new generic drugs. *The English version of China's RLD catalog will be updated in BaiPharm Database.

2. NMPA Announces Nine Rx-to-OTC Switches

In July 2021, NMPA granted nine prescription (Rx) drugs with over-the-counter (OTC) status. Marketing authorization holders (MAHs) of the drugs shall submit supplemental applications for changing drug labels to provincial medical products administrations, and notify the changes to relevant healthcare institutions and suppliers. *The English version of China's OTC catalog will be uploaded to BaiPharm Database.

3. NMPA and CNIPA Rolls Out Measures for Resolving Drug Patent Disputes

On July 4, NMPA and China National Intellectual Property Administration (CNIPA) announced the Measures for Implementing the Early Resolution Mechanism for Drug Patent Disputes (Trial) with immediate effect.²

The document is intended to balance the development of generic drugs and the patent protection of the approved brand-name drugs:

(1) It clarifies the bifurcated mechanisms, which means the brand-name drug patentees can file a lawsuit or request an administrative ruling against patent infringement by generics.

(2) It promises successful generic challengers a 12-month market exclusivity period.

Read more: China Rolls Out Measures to Establish Drug Patent Linkage System;

How Does China's Drug Patent Linkage System Work?

Comparing China and US Drug Patent Linkage Regulations

4. CDE Reminds AEP Manufacturers to Submit Annual Reports

On July 22, CDE reminded manufacturers of active pharmaceutical ingredients (API), pharmaceutical excipients and packaging materials (the three referred to as AEPs) to submit annual reports in time.³

For technical changes to APIs, the responsible persons shall first submit applications regarding changes. Only after approval can the manufacturers make the changes in practice accordingly.

For other changes, responsible persons shall update the on-file information on the DMF Filing Platform for AEPs, and list the changes in the annual report, which will be submitted in the first quarter of the following year.

The reminder is to encourage AEP companies, which failed to submit the reports on time due to the COVID-19 pandemic, to restart the production of AEPs. The submission deadline is currently not indicated but will be further noticed, says CDE.

5. CDE Issues the Guidance for Industry on Drug Application Formats & Requirements

On July 19, CDE published the General Format and Writing Guide for the Manufacturing Technique and Quality Standards of Traditional Chinese Medicines, Chemical Drugs, and Biological Products (hereinafter referred to as the Guide) with immediate effect.⁴

For applications submitted after the Guide's issuance:

   Applicants shall prepare drug registration applications according to the formats and requirements stipulated in the Guide.

For applications that have been submitted and in the process of review:

   (1) For applicants who haven't communicated or are in the middle of communication with CDE:

   The data relevant to manufacturing techniques and quality standards will be verified according to the Guide. 

   (2) For applicants have communicated with CDE.

   The data will be reviewed under the previous formats and requirements.

6. CDE Consults on Drug Guidelines and Technical Requirements

In July, CDE published 1 ICH guideline and its Chinese translation, 10 CDE-drafted guidelines, and 2 CDE-drafted technical documents for public comments.

One of the 13 guidelines—Guidelines for Clinical-Value-Oriented Clinical Trials of Antineoplastic Drugs⁵—rocked the pharmaceutical industry, inducing a plunge in share prices of contract research organizations (CROs) and anticancer drug makers. The document impacts the stock market because it says that drug R&D should center around patients' needs with orientation to clinical value.

The document means China encourages the R&D of innovator/first-in-class drugs while discouraging the me-too ones and disapproving the "me-worse" ones. China focuses on pushing the domestic pharma companies to produce drugs up to Chinese patients' higher expectations towards safety, treatment experience, and life quality. Thus, those products following behind the brand-name drugs will probably lose their competitiveness.

ChemLinked BaiPharm Team made a brief list of the documents under consultation. For further details and interpretations of the guidelines, please send an email to contact@chemlinked.com.