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PHARMACOVIGILANCEIN PEOPLE'S REPUBLIC OF CHINA
History of Pharmacovigilance of China: China went through many stages in developing pharmacovigilance system in the country. The National Center began as a project with support from China's Ministry of Health in 1988 and was formally established the following year.
The National Center joined World Health Organization's Collaborating Center for International Drug Monitoring ten years after it was founded (Uppsala Monitoring Centre). The center became a member of China's competent authority for drug regulation, the State Food and Drug Administration (SFDA), in 1999 and reports to both it and the Ministry of Health.
In 2011, it was clear that companies are responsible for establishing their ADR system; however, there was no formal inspection or ADR system developed. In 2015, China released guidelines to strengthen the supervision of the company’s activities on ADR monitoring. Until 2018, reporting rates for ADR were very less; in 2018, it was clarified to the companies that they are responsible for reporting ADRs to the center.
This responsibility aligns closely with global pharmacovigilance standards followed worldwide.
China Issues New Pharmacovigilance Quality Management Practice/Standards
On 7th May 2021, China’s National Medical Products Administration issued a new Pharmacovigilance Quality Management Practice/Standards (i.e. China GvP) to regulate and guide the pharmacovigilance activities of the drug marketing authorization holders and drug registration applicants. The Standards are implemented on 1st December 2021.
After releasing a consultation draft in December of last year, China's National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021. GVP, which was created to regulate and guide pharmacovigilance activities, is set to go into effect on 1st December 2021.
The guidance comes with different chapters (9 chapters) covering all requirements for MAH.
Glance of China’s Pharmacovigilance guidance
In order to regulate pharmacovigilance activities throughoutthe life cycle of drugs, this specification is formulated in accordance with the "Drug Administration Law of the People's Republic of China", "The Vaccine Administration Law of the People's Republic of China" and other relevant regulations.
Content of Chinese Good Pharmacovigilance Practices
| 1. General Principles | |
|---|---|
| 2. Quality Management | Fundamental Requirements |
| Internal Review | |
| Entrusted Management by Third-party | |
| 3. Personnel and Resources in the Organization | Organization (of Drug Safety Committee and Pharmacovigilance Departments) |
| Personnel and Training | |
| Equipment and Resources | |
| 4. Monitoring and Report | Information Collection |
| Evaluation and Feedback of the Report | |
| Report Submission | |
| • For suspicious and unexpected serious adverse reactions that are fatal or life-threatening within 7 days | |
| • For suspicious and unexpected serious adverse reactions within 15 days | |
| MAHs should register at China National ADR Monitoring System in order to submit cases | |
| 5. Risk Identification and Assessment | Risk Signal Detection |
| Risk Assessment | |
| Post-market Study on Drug Safety | |
| Periodic Safety Update Report (PSUR) | |
| 6. Risk Control | Measures for Risk Control |
| Risk Communication | |
| Pharmacovigilance Plan | |
| 7. File, Record and Data Management | Documents on Pharmacovigilance System, Standards and Procedure |
| Master Files on Pharmacovigilance System | |
| Records and Data | |
| 8. Pharmacovigilance During Clinical Trial | Fundamental Requirements |
| Risk Monitoring, Identification, Assessment and Control | |
| 9. Supplemental Principles |
Reference:
Announcement of the state food and drug administration on the issuance of the good management practice for pharmacovigilance (no. 65 of 2021) [Internet]. State food and drug administration may 7, 2021 [updated 2021 May 07; cited 2021 Dec 31]; Available from: Good management practice for pharmacovigilance.