China’s Phamacovigilance Regulators:

A Closer Look at NMPA, CDE, and CDR

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:
  • Medicinal
  • Medical Device
  • Cosemetics
  • Drug Abuse
China Direct ADR Reporting System for MAH, NCADRM Reference:
National Medical Device Adverse Event Monitoring Information System,NCADRM Reference:
Cosmetic Adverse Reaction Monitoring System Reference:
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