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

1. NMPA Rolls Out the 78th RLD List

2. NMPA Grants Six Rx-to-OTC Switches

3. NMPA Implements Electronic Submission for Import and Export License Applications of Anesthetics and Psychotropics

4. NMPA Issues Regulation on Exploratory Research on Drug Sampling and Testing

5. NMPA Releases the 2023 Report on Drug Sampling and Testing

6. Center for Drug Reevaluation Issues the 2023 Report on ADR Monitoring

7. China Releases Pharmaceutical Guidelines

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

1. NMPA Rolls Out the 78th RLD List

On March 12, 2024, the NMPA rolls out the 78th list of reference listed drugs (RLDs). The list encompasses 28 products, including Orion Corporation’s Salbutamol Sulfate Inhalation Powder and Merck Europe B.V.’s Tepotinib Hydrochloride Tablets (Tepmetko). For the full OTC catalog, please visit BaiPharm Database.

2. NMPA Grants Six Rx-to-OTC Switches

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

1) Pharynx and Larynx-clearing Granules (Qinghouye Keli)

2) Gushen Mixture (Gushen Heji)

3) Qingre Jiedu Tablets (Qingre Jiedu Pian)

4) E‘jiao Danggui Capsules (E'jiao Danggui Jiaonang)

5) Qishen Buqi Capsules (Qishen Buqi Jiaonang)

6) Aescine Sodium Liniment

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

3. NMPA Implements Electronic Submission for Import and Export License Applications of Anesthetics and Psychotropics

Starting from March 26, 2024, the NMPA has implemented the use of electronic documents for certain procedures related to the import and export of anesthetics and psychotropics. This transition to electronic form applies to specific documents without changing the acceptance, review, and certificate issuance process. Consequently, there will be no requirement for paper documents, and they will not be issued.

The documents affected by this change include:

• Application dossier and supplemental documents for import and export licenses.

• Administrative letter confirming the acceptance of the application.

• Import and export licenses.

Additionally, the NMPA mandates that applicants who successfully obtain import and export licenses must retain certain documents for a period of two years from the certificate’s expiration date. These documents include:

• The original import license issued by the importing country involved in the application.

• The original documents for notarization or certification demonstrating the import and export qualification of the applicant organization.

4. NMPA Issues Regulation on Exploratory Research on Drug Sampling and Testing

On March 29, 2024, the NMPA published the Principles and Procedures for Exploratory Research on Drug Sampling and Testing. Exploratory research refers to further analysis and research on the quality of drug samples during sampling and testing, in addition to the examination and determination of whether the drugs comply with the current standards.

Exploratory research involves the use of inspection items and testing methods beyond the drug standards, based on regulatory needs, to address potential quality risks with the sampled drugs.

In principle, for one drug selected for exploratory research, the number of marketing authorization holders (MAHs) for products (with the same generic name of the drug) currently in production will be no less than three. If there are three or fewer MAHs, samples will be collected from all of them. If there are more than three MAHs, the samples will cover over 70% of the total number of the MAHs.

5. NMPA Releases the 2023 Report on Drug Sampling and Testing

On March 26, 2024, the NMPA published the 2023 Report on Drug Sampling and Testing, which focused on the examination of 132 drugs and traditional Chinese medicine (TCM) decoction pieces. The sampled drugs encompass the following categories:

• 74 chemical drugs;

• 43 Chinese patent medicines;

• 9 TCM decoction pieces;

• 6 biological products.

A total of 18,762 batches of products were included in the sampling and testing process. These batches consisted of 4,272 batches in the manufacturing stage, 13,248 batches in the supply chain (including 207 batches for online sales), and 1,242 batches in use.

The companies under scrutiny included 1,114 manufacturers, 2,528 suppliers, and 511 organizations that use the drugs.

6. Center for Drug Reevaluation Issues the 2023 Report on ADR Monitoring

On March 26, 2024, the Center for Drug Reevaluation, operating under the NMPA, published the 2023 Report on Adverse Drug Reaction (ADR) Monitoring. According to the report, the national ADR monitoring system received a total of 2.419 million reports on new and serious drug ADR or adverse events during the previous year. Among these reports, 833,000 were related to new and serious ADRs or adverse events.

The majority of these reports, accounts for 90.1%, originated from healthcare institutions.  Additionally, 6.2% of the reports came from drug suppliers, 3.5% from MAHs, and 0.1% from other sources.

7. China Releases Pharmaceutical Guidelines

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

8. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In March 2024, the Chinese Pharmacopoeia Commission released the following 44 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 | February 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | January 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | December 2023