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

1. China CDE Accepts Online Submission of Electronic Drug Registration Documents

On July 1, China CDE announced the launch of a trial program for the online submission of electronic drug registration documents. Starting from the announcement date, applicants can submit related documents online except for those exceeding 10GB. The trial is applicable to electronic drug registration documents prepared according to the Technical Requirements for Electronic CD-ROM Submissions or the Technical Standards for eCTD.

2. China Customs Consults on the Importation of Bezoar

On July 1, China Customs solicited public opinions on allowing the importation of bezoar from countries or regions without mad cow disease bans and meeting China's quarantine and drug quality standards for trial use in traditional Chinese medicine (TCM) production. This trial will last for two years from the announcement date. Following this period, the use of imported bezoar will be progressively extended nationwide based on the trial's outcomes.

The first trial regions are Beijing, Tianjin, Hebei, Shanghai, Zhejiang, Jiangxi, Shandong, Hunan, Guangdong, Sichuan, Fujian, and Guangxi.

Applicants for importing bezoar must be marketing authorization holders for TCM products containing bezoar within the trial regions. The imported bezoar is solely for the applicant’s own use in manufacturing related TCM products and cannot be sold. 

3. China NMPA Grants Three Rx-to-OTC Switches

In July, NMPA granted over-the-counter (OTC) status to three previous prescription drugs:

• Yuxincao Qinlan Heji

• Metronidazole Vaginal Gel

• Naftifine Hydrochloride and Ketoconazole Cream

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

4. China NMPA Consults on Good Manufacturing Practices for Excipients and Packaging Materials

On July 18, China NMPA issued draft guidelines for Good Manufacturing Practices for Pharmaceutical Excipients and Good Manufacturing Practices for Pharmaceutical Packaging Materials for public consultation. In the guidelines, the NMPA highlighted three key points for improving the oversight of pharmaceutical excipients and packaging materials:

• manufacturers should develop and enhance their quality management systems;

• drug marketing authorization holders should strengthen material quality control;

• regulatory authorities should bolster supervision.

5. China NMPA Launches Pilot Program to Speed Up Approval for Innovative Drug Clinical Trials

On July 31, China NMPA introduced a pilot program to improve the review and approval process for innovative drug clinical trials. This initiative aims to create a system and mechanisms that significantly boost the quality and efficiency of clinical trials. To be specific, the goal is to complete the review and approval of innovative drug clinical trial applications within 30 working days. The pilot program focuses on clinical trial applications for Class 1 innovative drugs (excluding cell and gene therapy products, vaccines, etc.). Applicants are not restricted by location but must have at least three approved clinical trial applications for innovative drugs, extensive experience in conducting clinical trials and managing drug safety, and the ability to carry out a thorough risk assessment and develop a robust risk management plan before submitting application for Class 1 innovative drugs. Information on the specific pilot cities will be released in future announcements.

6. China Releases Pharmaceutical Guidelines

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

7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In July 2024, the Chinese Pharmacopoeia Commission released 153 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.

Excerpt of the 153 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 | June 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | May 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | April 2024