Monthly Recap: China Pharmaceutical Regulatory Updates | July 2022

Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards, mainly issued by the following authorities:

• National Medical Products Administration (NMPA);

• NMPA's Center for Drug Evaluation (CDE);

• National Health Commission (NHC);

• National Healthcare Security Administration (NHSA);

• National Joint Drug Procurement Office;

• Chinese Pharmacopoeia (ChP) Commission.

For more details about the summarized contents below, please send an enquiry to contact@chemlinked.com.

1. China's 7th Volume-based Procurement Includes 327 Drug Products

On July 18, China National Joint Drug Procurement Office announced the official list of 327 drug products for the 7th volume-based procurement (VBP).¹ 217 bid-winning companies will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer. Please refer to BaiPharm's previous report for more details.

2. China NMPA Grants One Rx-to-OTC Switch

On July 11, China NMPA granted the OTC status to a former prescription drug Glucosamine Potassium Sulfate Tablets.² View China's OTC medicine list at BaiPharm Database. Find out how to sell OTC drugs to China via cross-border e-commerce at BaiPharm Insight/Webinar.

ChemLinked BaiPharm Webinar: How to Sell OTC Drugs to China via Cross-border E-commerce

3. China NMPA Issues the 56th List of RLDs

On July 22, China NMPA released the 56th list of reference listed drugs (RLDs), including Teva Pharmaceuticals' Floxapen, Novartis Japan K.K.'s Betoptic and other 72 drugs.³ RLDs are reference products to which that generic drugs shall be equivalent in quality and efficacy. View the RLD lists at BaiPharm Database.

BaiPharm Database

4. China NMPA Implements Vaccine Manufacture & Distribution Rules

On July 8, China NMPA started implementing the Administrative Rules on Vaccine Manufacture and Distribution (hereafter referred to as the Rules).⁴ According to the Rules, China adopts the marketing authorization holder (MAH) system for vaccines. MAHs shall take the primary responsibilities for vaccine's safety, efficacy, and quality controllability, and manage the manufacture and distribution of vaccines. Check out more details at BaiPharm News.

5. China CDE Consults on Procedures for Starting For-cause Inspections

On July 7, CDE released the draft of Work Procedures for Initiating For-cause Inspections During Drug Review for public comments.⁵ For-cause inspections will be initiated by CDE if the drug application data are found to be suspiciously inauthentic or the drugs are reported to have problems during the review, and the issues need to be verified on site. When necessary, CDE can conduct sample tests.

Related Article: China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications

6. China CDE Releases Q&As on Immediate Report of Adverse Drug Reactions (ADRs) in Clinical Trials

On July 19, CDE consulted on the Q&As on the Immediate Report of Safety Data During Drug Clinical Trials (Version 2.0).⁶ CDE clarifies the scopes of drugs and clinical trials for which applicants should immediately report the unexpected and severe ADRs that are confirmed/suspected to be relevant to the test drugs.

The involved drugs cover traditional Chinese medicines, chemical drugs, and biological products, including vaccines.

The clinical trials include:

• Phase I/II/III clinical trials related to drug registration;

• Bioequivalence studies approved according to investigational new drug (IND) applications;

• Phase IV clinical trials particularly required in the drug approval document;

• Clinical trials required for drugs with conditional approval.

• Clinical trials required for marketed drugs that apply for adding a new target group or a new indication.

• Clinical trials required for marketed drugs that have major variations (e.g. new dosage form, new administration route, new manufacturing technique, etc.)

Time limits⁷ for the immediate reports:

Ÿ   For unexpected and severe ADRs that are deadly or life-threatening, the applicant should report them as soon as possible—no later than the 7th day from the first knowledge* of the ADRs. The applicant should complete the follow-up information in the subsequent 8 days after the report date.

Ÿ   For unexpected and severe ADRs that are neither deadly nor life-threatening, the applicant should report them as soon as possible—no later than the 15th day from the first knowledge of the ADRs.

*The first knowledge means that the applicant has known about the ADRs for the first time. The day when the applicant gets the first knowledge is defined as the zeroth day.

Related Article: China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports

7. Pharmaceutical Guidelines/Standards

Read More

• Monthly Recap: China Pharmaceutical Regulatory Updates | June 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | April 2022

Recommended 

Get Access to English Translation of Chinese Pharmacopoeia StandardsDownload for Free | 2021 China CDE Drug Evaluation Report