Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023

Editor's Notes: Monthly recap is a collection of China's laws, regulations, policies, and standards on medicines, including chemicals and biologics. Generally, they are issued by 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 November 2023.

1. China NMPA Applies for PIC/S Membership

2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs

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

4. China Includes 195 Drug Products in Its 9th National VBP

5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions

6. China NMPA Consults on Anesthetics and Psychotropics Regulations

7. China CDE Releases Pharmaceutical Guidelines

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

1. China NMPA Applies for PIC/S Membership

On November 9, 2023, China NMPA announced that Pharmaceutical Inspection Co-operation Scheme (PIC/S) had confirmed the NMPA’s applicant status. NMPA said it would continue to seek the full membership to enhance inspection system and standards as well as promote the modernization of drug regulation in China.

2. China to Adopt System for E2B (R3) Electronic Transmission of ICSRs

On November 1, 2023, China CDE and National Center for ADR Monitoring jointly announced that they would adopt the same system for electronic transmission of individual case safety reports (ICSRs) according to the ICH E2B (R3) message standard.

The system’s trial operation will last one year, starting from 17:00 pm on November 6, 2023. During the trial period, users who are registered with the old system can submit ICSRs via either the new or old system, while new users must submit ICSRs through the new system.

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

On November 22, 2023, China NMPA declared the approval of three Chinese patent medicines for of Rx-to-OTC switches. The medicines are as follows:

1) Lotus Cough Relief Tablets (Lianhua Qingke Pian);

2) Ziyin Yiwei Capsules (Ziyin Yiwei Jiaonang);

3) Pediatric Qizha Oral Solution (Xiao'er Qizha Koufu Ye).

View the full OTC Catalog at BaiPharm Database.

4. China Includes 195 Drug Products in Its 9th National VBP

On November 16, 2023, China Joint Drug Procurement Office announced the official list of 195 products (44 drugs when classified by active ingredients) that have successfully won the bid to participate in the 9th national volume-based procurement (VBP) program, a program of bulk-purchase of medicines for public healthcare institutions. The procurement process is scheduled to commence in March 2024, and the specific commencement dates will be released by local governments.

5. China NMPA Issues Inspection Regulation on Clinical Trial Institutions

On November 3, 2023, China NMPA released the Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (Trial), which is set to take effect on March 1, 2024. The regulation is for inspecting whether the institutions follow GCP and other relevant rules in the process of filing for and conducting clinical trials for drug registration.

6. China NMPA Consults on Anesthetics and Psychotropics Regulations

On November 6, 2023, China NMPA published the draft Administrative Regulations on Experiments and Researches on Anesthetics and Psychotropics for public feedback. The draft requires that applicants must get NMPA’s approval before conducting pre-clinical experiments and researches with the aim of obtaining marketing authorization for anesthetics and psychotropics in China.

7. China CDE Releases Pharmaceutical Guidelines

In November 2023, CDE issued the following guidelines:

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In November 2023, the Chinese Pharmacopoeia Commission released the following draft standards. 

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

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | August 2023