Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) has given policy guidelines for inspections of manufacturers keeping in view the suggestions/guidelines of WHO for reliance on other regulatory authorities. Accordingly, the revised “Policy for inspections of manufacturers abroad” as approved by the Policy Board under Section 11 (I) (a) of the DRAP Act, 2012, as under:-
Month: July 2022
DRAP notified National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules, 2022
Drug Regulatory Authority of Pakistan (DRAP) , in pursuance to the enactment of Pharmacovigilance Rules, 2022 has notified the National Pharmacovigilance Centre, with the aim to further enhance the Pharmacovigilance activities includes collecting, analyzing, monitoring, and preventing adverse effects in the therapeutic goods.
DRAP also encourages all healthcare professionals to establish the practices of pharmacovigilance in the country as they have pivotal role in monitoring the safety and efficacy of therapeutic goods, particularly for newly-marketed product.
The Authority, under Rule 3(1) read with Rule 3 (2) of the Pharmacovigilance Rules, 2022, notified the National Pharmacovigilance Centre under the Division of Pharmacy Services, DRAP.
The safe use of drugs, vaccines, medical devices and other therapeutic goods medicines is the most important criteria for DRAP to protect the public health and integrity of national healthcare system. Pharmacovigilance is the mechanisms to map and ensure the safety of therapeutic goods throughout their life span – from clinical trials to patient or consumer.
The importance of Pharmacovigilance is increased further in the current era due to arrival of novel of biopharmaceutical products and innovative technologies in healthcare practices.
National Pharmacovigilance Center (NPC) is working at DRAP and Pakistan is a full member of the WHO Programme for International Drug Monitoring.
Two Provincial Pharmacovigilance Centres in Punjab and Islamabad are also working in addition to a Centre of EPI (immunization programme), collecting ADR data and collaborating with the National Centre. National Pharmacovigilance Centre (NPC) has also established a Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
NPC is Coordinating with other provinces/administrative territories, PHPs for establishment of their PV centers and also communicating with manufacture and importers of therapeutic goods for establishment of their pharmacovigilance system and reporting of ADRs to DRAP.
NPC has also published various documents and Guidelines for Stakeholders on pharmacovigilance activities, including :-
- Pakistan National Pharmacovigilance Guidelines
- Good Vigilance Practice Guidelines for Pharmaceutical Companies
- Pharmacovigilance Guidelines for Healthcare Professionals
- Pharmacovigilance Guidelines for Patients Pharmacovigilance
- Guidelines for Public Health Programmes.
