Exploring the responsibilities of NMPA, CDE, and CDR in China’s PV system
SAMR – State Administration for Market Regulation
The SAMR is a full ministry agency reporting directly to the State Council
of the People’s Republic of China. Under the SAMR is the NMPA, which
regulates clinical trials and pharmaceutical market industry.
NMPA – National Medical Products Administration
China NMPA (Formerly CFDA) is the regulatory authority responsible for
China’s drug surpervision and management, which includes implementing
regulations and guidelines for ensuring drug safety in clinical trials,
marketing authoritisations and pharmacovigilance policies in China.
Other responsibilities:
Management and supervision of drugs, cosmetics, and medical devices.
Establishing standards for drugs, cosmetics, and medical devices.
Managing registration of drugs, cosmetics, and medical devices.
Handling quality management for all regulated products.
Risk management of regulated products after listing.
Managing qualification and registration of licensed pharmacists.
Inspection and supervision of drugs, cosmetics, and medical devices.
Handling foreign exchanges and other interactions with international
parties.
Guiding drug supervision and administration departments under
government jurisdiction.
China CDE (Centre for Drug Evaluation)
NMPA’s Center for Drug Evaluation (CDE) is responsible for the evaluation
of drug clinical trial applications, drug marketing authorization
applications, supplementary applications, and overseas drug production
registration applications. China’s Centre for Drug Evaluation (CDE) is
also responsible for pharmacovigilance reporting pre-marketing Adverse
Events, including Serious Adverse Events and Unintended Serious Adverse
Events in China.
CDR-Centre for Drug Reevaluation, NMPA | National Center for ADRMonitoring
China’s Centre for Drug Reevaluation (CDR) is responsible for the
regulation of China’s pharmacovigilance, post-marketing pharmacovigilance,
and colleagues are responsible for issuing some technical standards and
guidelines.
ADR Reporting in China: Official System explained
National Adverse Drug Reactions Monitoring System (NADRMS)
NADR Monitoring System is used for Adverse Events Reporting and
Management:
