Post market surveillance of medicines and allied substances

Section 72 of the PMRA Act mandates the Authority to establish and maintain a national pharmacovigilance (PV) system. PMRA is the 135th member of the WHO’s Program for International Drug Monitoring (PIDM) since March 2019.

Under the PV system the Authority;

  • Receives individual case safety reports (ICSR) from health care workers and the public using special forms;
  • Conducts causality assessment of ICSR; and
  • Coordinates the implementation of risk management plans

The authority undertakes both passive and active safety surveillance implemented through public and CHAM hospitals as well as public health programs. In this regard the Authority is involved in training of healthcare professionals in reporting of Adverse Events Following Immunization and Adverse Drug Reactions.