ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

May 7, 2021

EFFECTIVE DATE:

December 1, 2021

On May 7, 2021, the National Medical Products Administration (NMPA) promulgated the Good Pharmacovigilance Practices (GVP), which shall take effect as of December 1, 2021.

In 2003, the World Health Organization defined pharmacovigilance as the science and activity of detecting, evaluating, understanding and preventing Adverse Drug Reactions (ADR) or any other drug-related problems, a definition that has been used ever since. In 2018, NMPA joined the International Council for Harmonisation (ICH) Management Committee and began to gradually implement the ICH Guidelines for detecting and evaluating ADRs. The newly revised PRC Drug Administration Law (DAL) proposed the establishment of a pharmacovigilance system in China, which is the direct basis for the formulation of GVP.

The GVP mainly applies to the Market Authorization Holders (MAH) (including sponsors of clinical trials), with a focus on technical standards and technical guidance. With the exception of  the first chapter and the eighth chapter of the GVP, all other chapters provide for the pharmacovigilance activities of MAH, mainly specifying the elements of MAH pharmacovigilance system, ADR monitoring and reporting, drug safety risk identification, evaluation and control, document and data management.

As the first supporting document on pharmacovigilance after the revision of DAL, the GVP sheds light on the following points: (i) Pharmacovigilance activities shall take place in the whole life cycle of drugs, including collection, identification, evaluation and control requirements of ADRs not only after the drugs are marketed, but also during the drug clinical trials; (ii) It clarifies the key contents and processes of pharmacovigilance activities to be carried out by MAH and the sponsors; (iii) It requires effective and differentiated pharmacovigilance activities based on the safety characteristics of different types of drugs, such as innovative drugs, traditional Chinese medicines and ethnic medicines.

Reference:

国家药监局关于发布《药物警戒质量管理规范》的公告(2021年 第65号)