Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024

Editor's Notes: Monthly recap is a collection of China's laws, regulations, standards, and policies on chemical drugs and biological products. Generally, the regulatory updates are from these authorities:

• National Medical Products Administration (NMPA);

• Center for Drug Evaluation (CDE), NMPA;

• National Health Commission (NHC);

• National Healthcare Security Administration (NHSA);

• National Joint Drug Procurement Office;

• Chinese Pharmacopoeia (ChP) Commission. 

The following are the regulatory updates in February 2024. 

1. NMPA Issues the 2023 Drug Evaluation Report

2. NMPA Rolls out the 76th and 77th lists of RLDs

3. NMPA Specifies Administrative Penalties for Drug-related Illegalities

4. China Releases Pharmaceutical Guidelines

5. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

1. NMPA Issues the 2023 Drug Evaluation Report

On February 8, 2024, NMPA published the 2023 Drug Evaluation Report. According to the report, in 2023, NMPA granted approval to a total of 40 first-class innovative drugs, which can be categorized as follows:

• 9 drugs were approved through priority review.

• 13 drugs were granted conditional approval.

• 8 drugs were granted breakthrough therapy designation during clinical studies.

• 4 drugs were granted special approval for the treatment of COVID-19.

Furthermore, NMPA approved 45 drugs for rare diseases, 92 pediatric drugs, and 3 CAR-T therapeutic products last year.

2. NMPA Rolls out the 76th and 77th lists of RLDs

On February 4 and 8, 2024, NMPA unveiled the 76th and 77th lists of reference listed drugs (RLDs) respectively. The two lists consist of a total of 90 products, which include Riluzole Oral Suspension and Carglumic Acid Dispersible Tablets. Access the complete RLD catalog at BaiPharm Database.

3. NMPA Specifies Administrative Penalties for Drug-related Illegalities

On February 23, 2024, NMPA released the Applicable Rules for the Discretion of Administrative Penalties in Drug Supervision and Administration, which is scheduled to become effect on August 1, 2024. The rules specify the circumstances in which administrative penalties should be imposed, as well as the type and degree of penalty for various unlawful behaviors.

For instance, severe administrative penalties will be imposed on individuals engaged in the production, sale, or use of counterfeit drugs, substandard drugs, or Class 3 medical devices that fail to meet mandatory standards or the technical requirements of registered products, and these activities primarily target pregnant women, children, and critically ill patients.

4. China Releases Pharmaceutical Guidelines

In February 2024, China unveiled the following 12 guidelines on chemical drugs and biological products.

5. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In February 2024, the Chinese Pharmacopoeia Commission released the following 46 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.

Contact BaiPharm if you are interested in learning more about drug registration regulations in China.

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | January 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | December 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023