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

1. NMPA to Streamline Process for Transferring Overseas Drug Manufacturing Sites to China

On January 24, 2024, NMPA issued a draft of the Notice on Optimizing Marketing Authorization Applications for Transferring Manufacturing Sites of Approved Overseas Drugs to China.

The term "approved overseas drugs" refers to drugs that have been previously approved by China but are manufactured outside of China. 

The draft brings encouraging news as it suggests that China may accept the original registration application dossier on approved overseas drugs, including documents related to chemistry, manufacturing, and controls, non-clinical and clinical studies, if they remain applicable.

However, specific studies on the transfer of manufacturing sites will still be required, and the dossier requirements on these studies will be issued by CDE.

Another positive aspect mentioned in the draft is that the NMPA acknowledges that such applications for originator chemical drugs and biological products are eligible for priority review.

2. CDE Conditionally Waives Registration Documents for Overseas Manufactured Drugs

As the Convention Abolishing the Requirement of Legalization for Foreign Public Documents has been implemented in China, CDE announced on January 23, 2024, that in accordance with the convention, it waives the need for notarial documents from the country of origin and the Chinese embassy/consulate to the country, for overseas manufactured drugs, except in situations where the convention states that it is non-applicable. 

For overseas manufactured drugs, CDE only requires apostilles for the following documents:

• Documents that demonstrate the marketing authorization of the drug product in the country of origin;

• GMP certification documents;

• Documents that prove the authorization for changes made to the drug product. 

3. NMPA Rolls out the 75th RLD List

On January 24, 2024, NMPA rolled out the 75th list of reference listed drugs. The list encompasses 82 products that serve as reference drugs, to which relevant generic drugs should demonstrate equivalence. View the whole list at BaiPharm Database. 

4. NMPA Outlines Key Considerations for Inspecting Third-party Platforms for Online Drug Sales

On January 5, 2024, NMPA issued the Guidance for the Inspection of Third-party Platforms for Online Drug Sales (Trial) with immediate effect. 

According to the guidance, the platforms’ registered address of companies conducting third-party platform businesses and their operating premises. If necessary relevant premises may also be subject to extended inspections.

The guidance also outlines the key considerations indicating platforms in the following scenarios are more likely to receive routine/for-cause inspections.

Key considerations for routine inspections:

1. Companies conducting third-party platform businesses for the first time.

2. Companies conducting third-party platform businesses without a background in pharmaceutical distribution.

3. Companies with large-scale operations, wide coverage, and fairly substantial business volume in third-party platforms.

Key considerations for for-cause inspections:

1. Indications from online monitoring, public complains, whistleblowing, public opinions, and random inspections suggesting potential risks.

2. Failure to timely identify, detect, prevent, and report relevant risks.

3. Insufficient strict management of drug information, links, drug sales activities on the platform.

4. Repeated non-compliance with inspection requirements in the past.

5. Significant adjustments in the management system and key positions.

6. Failure to promptly rectify identified deficiencies during supervisions and inspections.

7. Other circumstances deemed necessary for inspection by the drug regulatory department. 

5. CFDI Issues Guidance for Annual Reports of Clinical Trial Institutions

On January 25, 2024, the Center for Food and Drug Inspection (CFDI) of NMPA released the Writing Guidance for Annual Work Reports of Drug Clinical Trial Institutions. According to the guidance, the reports should cover the following seven aspects, and if no information is available for any of them, the reasons should be stated:

1. Construction of organization and administrative system

2. Personnel training

3. Changes in the document system

4. Implementation of quality control

5. Ethnics committee

6. Previous inspections conducted by domestic and overseas inspectors.

7. Plan for the upcoming year. 

6. China Releases Pharmaceutical Guidelines

In January 2024, China started implementing the following 11 guidelines.

7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In January 2024, the Chinese Pharmacopoeia Commission released the following 31 draft standards on chemical drugs, biological products, 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 | December 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | November 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023