China pharmacovigilance regulations have been undergoing significant reform reinforced by recently issued Good Pharmacovigilance Practices (GVP) (2021, Decree No. 65).
In addition to the regulations, the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) and National Centre for Adverse Drug Reaction (ADR) Monitoring (NCADRM) of China have also released guidelines and standards for implementing pharmacovigilance duties in China.
Under this framework, each drug Marketing Authorization Holder (MAH) requires to monitor drug safety and operate a pharmacovigilance system or by appointing a qualified service provider for carrying out pharmacovigilance activities to ensure that all the ADRs are being reported, evaluated and controlled.
For an overview of these requirements, we have summarized the pharmacovigilance regulations and standards in the table below.
|
CATEGORY |
REGULATIONS |
SUMMARY |
|---|---|---|
| General Law & Regulation | Drug Administration Law (2019, No. 31) | Regulatory basis for the establishment of pharmacovigilance system, requiring each drug MAH and health authority to monitor, identify, evaluate, and control ADRs and any other safety risks of a drug both before and after approval. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html(Chinese) |
| General Law & Regulation | Good Pharmacovigilance Practices (2021, No. 65) | General standards for the safety monitoring of drugs throughout their life cycle and guidance for drug MAHs, medical facilities, and health authorities on pharmacovigilance. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html (Chinese) |
| Premarketing Regulations | Good Clinical Practice (2020, No. 57) | Basic requirements for premarketing safety monitoring, incl. defining ADRs and Suspected Unexpected Serious Adverse Reactions (SUSARs), requiring drug MAHs to report ADRs in a timely manner and researchers to provide safety reports. https://www.nmpa.gov.cn/yaopin/ypggtg/20200426162401243.html (Chinese) |
| Premarketing Regulations | Announcement on Adapting Tier 2 ICH Guidelines (2018, No. 10) | A formal statement on adapting Tier 2 ICH Guidelines E2A, E2B, E2D, M4, M1 in China.https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180125175101686.html (Chinese) |
| Premarketing Regulations | Announcement on Adjusting Review and Approval Process of Drug Clinical Trials (2018, No. 50) | Requirements for a drug MAH to submit Development Safety Update Report (DSUR) after obtaining the clinical trial approval, file supplementary application for any change to the drug that could increase safety risks, and report SUSARs during clinical trials. https://www.nmpa.gov.cn/xxgk/ggtg/ywlchshyjgrdgg/20180727172901286.html (Chinese) |
| Premarketing Regulations | Standard and Process of Safety Data Fast Reporting during Drug Clinical Trials (2018) | Guidance for drug MAHs on identification and fast reporting of SUSARs and other serious safety risks during clinical trials, incl. responsibilities, timeline, and submission requirements.http://www.cde.org.cn/news.do?method=largeInfo&id=90755b9d6035c1b4 (Chinese) |
| Premarketing Regulations | Provisions for Safety Data Assessment and Management during Drug Clinical Trials (2020, No. 5) | Requirements for drug MAHs to assess and manage drug safety data during clinical trials under the review of CDE. For any clinical study suspended or terminated due to safety risks, the drug MAH can communicate with CDE about resuming the study. http://www.cde.org.cn/news.do?method=largeInfo&id=938b81c153eaf85e (Chinese) |
| Premarketing Regulations | Management Provisions for Development Safety Update Report (2020, No. 7) | DSUR drafting and submission requirements for drug MAHs. http://www.cde.org.cn/news.do?method=largeInfo&id=3cad3925b893ab31 (Chinese) |
| Postmarketing Regulations | Provisions for Reporting and Monitoring of Adverse Drug Reactions (2011, No. 81) | Fundamental requirements and systemic concept of ADR reporting and monitoring by drug manufacturers, distributors, medical facilities and health authorities.https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20110504162501325.html (Chinese) |
| Postmarketing Regulations | Standard of Periodic Safety Update Report (PSUR) Drafting for Marketed Drugs (2012, No. 264) | Guidance for drug MAHs on drafting the PSURs. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20120906145901535.html (Chinese) |
| Postmarketing Regulations | Guidance on Periodic Safety Update Reports (PSUR) Review for Marketed Drugs (2012, No. 27) | Guidance for health authorities on reviewing these PSURs. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/201211/t20121123_35783.html (Chinese) |
| Postmarketing Regulations | Guidance for Drug Manufacturers on Intensive Drug Monitoring (2013, No. 12) | Guidance for drug manufacturers on intensive safety monitoring of new drugs within 5 years after approval and imported drugs within 5 years after first-time import. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20130325113801579.html (Chinese) |
| Postmarketing Regulations | Guidance on Inspection of Adverse Drug Reaction Reporting and Monitoring (2015, No. 78) | Guidance for health authorities on inspection of ADR reporting and monitoring by drug manufacturers, incl. the purpose, plan, implementation and documentation requirements. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20150702120001584.html (Chinese) |
| Postmarketing Regulations | Announcement on Direct Reporting of Adverse Drug Reactions by Drug Marketing Authorization Holders (2018, No. 66) | A comprehensive regulation that specifies all the responsibilities and duties of a drug MAH in ADR reporting and monitoring. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180930174301286.html (Chinese) |
| Postmarketing Regulations | Guidelines for Collection and Reporting of Individual Adverse Drug Reactions (2018, No. 131) | Guidance for drug MAHs on data collection, recording, reporting, verification, assessment and submission for Individual Case Safety Reports (ICSR), patient follow-up and case investigation. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20181221172901438.html (Chinese) |
| Postmarketing Regulations | Guidelines for Review of Literature about Marketed Drug Clinical Safety (2019, No. 27) | Guidance for drug MAHs on searching, screening, collection, review, and analysis of literature about clinical safety of marketed drugs and drafting the literature review reports. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20190618165701432.html (Chinese) |
| Postmarketing Regulations | Guidance on Annual Pharmacovigilance Report Drafting by Drug Marketing Authorization Holders (2019) | Guidance for drug MAHs on drafting the annual pharmacovigilance report, incl. content and format requirements for the report and a report template. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/201911/t20191129_46859.html (Chinese) |
| Postmarketing Regulations | Guidelines for Pharmacovigilance Authorization Agreement Drafting (2020) | Guidelines for drafting the pharmacovigilance authorization agreement, incl. principles, scope of work, responsibilities, etc. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202006/t20200604_47472.html (Chinese) |
For the English version of the above links, please contact us.
Except for the regulations and standards listed above, China has also adapted to several ICH guidelines for pharmacovigilance:
Premarketing Pharmacovigilance
- SUSAR reporting in clinical trials: ICH E2A, E2B (R3) and M1 (MedDRA) guidelines
- DSUR reporting in clinical trials: ICH E2F guideline
Postmarketing Pharmacovigilance
- Safety reporting: ICH E2B (R3), E2D and M1 (MedDRA) guidelines
- Periodic Benefit-Risk Evaluation Report (PBRER): ICH E2C (R2) guideline
For English translations or questions on China’s pharmacovigilance requirements, you may message us on: info@accestra.com
For further details on China pharmacovigilance history and MAH responsibilities, you may be interested in reading the following article: https://www.accestra.com/pharmacovigilance-pv-in-china/
Contact us for English translations or questions on China’s pharmacovigilance requirements.
- Find out more about China pharmacovigilance history and MAH responsibilities
