Currently, the established pharmacovigilance system in China is known as the National Adverse Drug Reaction Monitoring Information Network. The national ADR monitoring authority is the National Center for ADR Monitoring (NCADRM). Most provinces also have Provincial Center for ADR Monitoring (PCADRM), under which there is also a Prefectural and Country level for ADR monitoring (CADRMS). Adverse Drug Responses (ADRs) are reported by manufacturers, healthcare professionals and individuals to CCADRM or PCADRM in their provinces.
china’s Pharmacovigilance Structure
China’s Adverse Drug Reaction Moniotirng System (CADRMS):
The National Center for ADR Monitoring (NCADRM) responsibilities:
The NCADRM is responsible for collecting and assessing the reports from all PCADRMs and submitting the statistic report of ADR monitoring to the NMPA and NHFPC.
Provincial Center for ADR Monitoring (PCADRM) Responisbilities:
The PCADRM is responsible for collecting, verifying, analyzing and assessing reports incurred in the specific province and reporting the ADRs to NCADRM and PFDA.
China’s ADR Reporting Timelines:
*Reporting Time limits are Causality Assessments are measured in Working days.
Pharmaceutical Master File (PMF) submission:
The NMPA outlines that PMF requirements that include of drug alert, risk management plan, periodic safety update report, department and post responsibilities, work system, operation rules. A PMF is similar to a Drug Master File and Trial Master File, the PMF should be included in a new drug application or re-registration application.
MAH/applicant may submit PMF in the following situations:
- When MAH/applicant register a new drug.
- When MAH/applicant files re-register a drug application.
- Whenever NMPA(authority) recommends to deliver the PMF.
Pharmacological Master File Content:
The content of the PMF should include the following:
THE BASIC INFORMATION OF THE PERSON IN CHARGE OF DRUG ALERT
It should include detailed contact information, CV, main responsibilities and authority
THE ORGANIZATIONAL STRUCTURE OF THE APPLICANT / MAH
The organizational structure and relationship related to the development of drug alert work should be described;
DRUG SAFETY DATA SOURCES
The main units, methods and processes of drug safety information collection should be described;
DRUG SAFETY MONITORING METHODS
The locations, functions and operational responsibilities of computer systems and databases used to monitor drug safety information, carry out signal management activities and other risk management activities shall be described;
DRUG ALERT SYSTEM
The description of drug alert system and the quality control of the system should be provided;
DRUG ALERT PROCESS:
The catalogue of work systems and operating procedures related to drug alert work should be provided, and the storage mode of relevant records should be described.
DRUG SAFETY MONITORING METHODS
Methods and procedures for drug safety monitoring should be described;
Supporting materials to be provided.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.