China Implements New Rules on Drug MAH's Annual Reports

by Grace Wang Apr 21, 2022

On April 12, China National Medical Products Administration (NMPA) started implementing the Administrative Rules on Drug Annual Reports. It is the first time China has published detailed requirements for submitting annual reports since the submission became mandatory according to the Drug Administration Law revised in 2019.

1. Who Should Submit the Annual Report

Marketing authorization holders (MAH) of NMPA-approved drugs shall submit annual reports to the "Drug Annual Report Collection Module", an online system. A foreign MAH's annual report should be completed and submitted by its appointed Chinese legal agent that shares the joint liability with the MAH.

2. What Should Be Included in an Annual Report

An annual report consists of two parts1:

Part 1: General Information:

1.1 The MAH's information;

1.2 General information of the products owned by the MAH;

1.3 Summary of quality management;

1.4 Establishment and performance of the pharmacovigilance system;

1.5 Manufacturing tasks entrusted by overseas company (this item only applies to Chinese MAHs);

1.6 Inspections conducted by overseas regulator for the MAH.

Part 2: Product information:

2.1 The product's basic information;

2.2 Manufacturing and sales;

2.3 Post-marketing research and variation (changes of MAH, manufacturing sites, etc.) management;

2.4 Risk management.

Each annual report should be written according to NMPA's Drug Annual Report Template. Every year, an MAH should submit one report, which covers all the products owned by the MAH in principle.

3. When to Submit the Annual Report

The 2021 annual report should be submitted to the Drug Annual Report Collection Module before August 31, 2022. The subsequent annual reports should be submitted before April 30 of the following year. For example, the 2022 annual report's submission should be made before April 30, 2023.

If failing to submit the report in time, the MAH will receive a warning from NMPA. If continuing the wrongdoing after the warning, the MAH will even be subject to 100,000-500,000 yuan fines.

4. BaiPharm Offers Annual Report Services

As a leading regulatory consulting company, BaiPharm is experienced in helping MAHs compile, edit, and submit annual reports. Contact BaiPharm for professional services.

Read More

Decoding China's Marketing Authorization Holder (MAH) System

Grace Wang
ChemLinked Regulatory Analyst & Editor
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