Monthly Recap: China Pharmaceutical Regulatory Updates | April 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 April 2024.

1. China NMPA Adopts Electronic Documentation for Administrative Licensing in Drug Registration

On April 3, 2024, the National Medical Products Administration (NMPA) announced the adoption of electronic documentation for administrative licensing in drug registration. As of May 1, 2024, the NMPA will digitize administrative licensing documents related to drug registration, such as national drug standards, notices of termination for registration applications, and notifications of approval for the importation of reference drugs. These electronic documents will hold the same legal validity as their paper counterparts, ensuring a streamlined and effective process for drug registration.

2. China NMPA Rolls out the 79th RLD List

On April 16, 2024, the NMPA rolls out the 79th list of reference listed drugs (RLDs). The list encompasses 64 products, including Thiamine Hydrochloride Injection/Vitamin B1 Injection, Mavacamten capsules and Iloperidone Tablets. 

For the complete RLD List, please refer to the BaiPharm Database.

3. China Enhances Supervision and Management of Drug Operations

On April 22, 2024, the National Medical Products Administration (NMPA) issued an announcement regarding the further enhancement of the supervision and management of drug operations. The announcement consists of thirteen articles that provide specific provisions on the admission management of drug operation enterprises, the management of drug operation licenses, the standardization of drug operation practices, and the supervision and management of drug warehousing and logistics. 

4. China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China

On April 23, 2024, the NMPA published the Notice on Optimizing Marketing Authorization Applications for Transferring Manufacturing Sites of Approved Overseas Drugs to China.

The notice outlines the following three points.

1) In the case of drugs that have already received approval in China but are currently manufactured outside of China, if the applicant intends to transfer the manufacturing site to China, they must adhere to the requirements for and procedures of submitting drug marketing authorization applications.

2) For drugs mentioned in Point 1), for the marketing authorization application in China, the applicant is permitted to submit the original overseas marketing authorization dossier as supporting documentation, along with the research dossiers related to the transfer of the manufacturing site. The dossier requirements will be published by the Center for Drug Evaluation (CDE). 

3) For originator chemical drugs and biological products mentioned in Point 1, their marketing authorization applications will be admitted into the priority review process by the NMPA.

5. China NHC Undertakes the Management of Human Genetic Resources

On April 25, 2024, the China National Health Commission (NHC) issued an announcement, stating that starting from May 1, 2024, the management of human genetic resources would be undertaken by the National Health Commission instead of the Ministry of Science and Technology (MOST). The existing application process and platform (https://apply.hgrg.net) remains unchanged.

6. NMPA Grants Seven Rx-to-OTC Switches

In April 2024, NMPA granted over-the-counter (OTC) status to seven previously approved prescription drugs. They are:

1) Fuxuekang Granules (Fuxuekang Keli)

2) Xueshan Weibao Capsules (Xueshan Weibao Jiaonang)

3) Bismuth potassium Citrate Capsules

4) Weishuning Tablets (Weishuning Pian)

5) Qiushui Jianpi Powder (Qiushui Jianpi San)

6) Danzhi Xiaoyao Capsules (Danzhi Xiaoyao Jiaonang)

7) Linglianhua Granules (Linglianhua Keli)

For the complete OTC catalog, please refer to BaiPharm Database.

7. China Releases Pharmaceutical Guidelines

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

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In April 2024, the Chinese Pharmacopoeia Commission released 94 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.

Parts of the 94 draft standards

 Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | March 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | January 2024