Series of Training on National Pharmacovigilance System for Registration holders (Manufacturers and Importers)

The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services. This initiative is aimed at ensuring the safety of therapeutic goods. With its endeavour, Pakistan became the 134th full member of the Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre in 2018.

Subsequently, the DRAP notified Pharmacovigilance Rules, 2022 which outline the roles and responsibilities of pharmacovigilance stakeholders, including registration holders of therapeutic goods. The DRAP has also developed Guidelines on Good Pharmacovigilance practices for registration holders that outline step-by-step guidelines on the establishment of pharmacovigilance systems in pharmaceutical companies. The NPC has dedicated tools in place for the collection of adverse drug reaction reports (ADRs) from pharmaceutical companies (registration holders) such as E2B XML submission through dedicated email, and hard copy submissions via mailing address

Despite the above efforts of DRAP, very few pharmaceutical companies have established their pharmacovigilance centres and nominated their qualified persons for pharmacovigilance. Implementing pharmacovigilance rules, 2022 and establishing an effective pharmacovigilance system by all stakeholders, including registration holders is a prerequisite for ensuring the safety of medicines in Pakistan. This will reduce the risks associated with medications, thereby ensuring patient safety. This is why DRAP feels that there is a need to enhance the capacity of registration holders in respect to pharmacovigilance.

In this regard, the NPC, Division of Pharmacy Services, DRAP intends to conduct training of pharmaceutical companies (registration holders) on pharmacovigilance rules, guidelines and pharmacovigilance systems including collection and reporting of pharmacovigilance data. Three virtual training session will be conducted in the month of July 2024.