Month: April 2022
DRAP issues guidelines on Good Pharmacovigilance Practices for Product Registration Holders
Registration holders are stakeholders of pharmacovigilance who have valid registration of therapeutic goods. There are also legal obligations on registration holders to monitor the safety of therapeutic goods. Therefore, there is a need that they should have basic knowledge and understanding of pharmacovigilance activities to fulfil their legal obligations. The purpose of this guidance document is to provide a basic framework for the implementation of the pharmacovigilance programme of Pakistan and to ensure that registration holders are better equipped to monitor the safety of therapeutic goods and to detect, assess, understand, prevent and investigate ADRs/ AE and AEFI reports.
This guidelines intended to assist registration holders:
a. To develop a pharmacovigilance system and monitor the safety of therapeutic goods registered in their name;
b. Collect pharmacovigilance data, perform its assessment and accordingly submit to National Pharmacovigilance Centre (NPC), DRAP;
c. Cooperate with NPC in the performance of pharmacovigilance inspection;
d. Preparation and submission of periodic safety reports and risk management plan;
e. Design and conduct post-authorization safety studies; and
f. Detect, validate and assess signals and accordingly communicate to NPC and other stakeholders and considers options for risk minimization.
Click Here to access the guidelines.
Circular: Mecobalamin Manufacturing and Testing
Circular: Cefixime Capsule 200mg & 400mg Specifications.
DRAP holds meeting of provincials’ health departments and drug control organizations of all federating units to strengthen the regulatory oversight through an integrated and harmonized regulatory approach.
Drug Regulatory Authority of Pakistan (DRAP) is continuously engaged in strengthening national regulatory framework in collaboration with all stakeholders. In this context, a meeting of regulators was convened on 1st April, 2022 at Islamabad to review the all cross cutting regulatory functions. Senior managements from Drug Control Organizations, Quality Control Boards and Drug Testing Laboratories participated in the meeting.
