Legislation
Amended Drug Pricing Policy 2018
Notification regarding amendments in the Drugs (Research) Rules (S.R.O 168(I)/2025)
Notification regarding Therapeutic Goods (Advertisement) Rules, 2025
S.R.O. 1324(l)12024 – Revision of Regulatory Fee Notification
In exercise of the powers conferred by sub-section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), read with sub-rule (3) of Rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, the regulatory fees of various functions has been notified. The Notification as under:-
Introducing Centralized Case Management System for Enhanced Efficiency and Transparency
The Drug Regulatory Authority of Pakistan (DRAP) has introduced a centralized case management system, aimed at boosting operational efficiency and ease of doing business processes for the therapeutic goods industry. This system is designed to monitor the processing of applications and to enable applicants to track their regulatory submissions and furnish additional details as required, marking as a significant step towards enhancing transparency and efficiency.
All licensed / applicant of therapeutic goods manufacturers/importers/exporters/ clinical trial sites/ CROs etc can access this system on eAPP module (www.eapp.dra.gov.pk) of DRAP through their existing secured account credentials, effective from 29th May, 2024. This module ensures that submissions are forwarded to the Director of the concerned Divisions with visibility for applicants to track their cases and receive timely responses, under monitoring by the DRAP’s higher management.
We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations.
SRO 1710; MRP Fixation of Drugs
Model List of Essential Medicines 2023 (S.R.O. 1423 of 2023)
National Hazardous Waste Management Policy 2022
The National Hazardous Waste Management Policy, 2022 of Pakistan is a set of guidelines for the environmentally sound management of solid and hazardous waste in the country. The Ministry of Climate Change has formulated this comprehensive national level policy through consultative process with relevant stakeholders. This Policy is aimed at acting as an umbrella document to address the issue of hazardous waste.
Pharmaceutical Industry being a potential source of generating hazardous material as byproduct of its manufacturing, research and development processes. These involve handling of various chemical compounds which may be toxic, reactive, flammable or otherwise hazardous to human health and environment Therefore, proper management of hazardous waste in pharmaceutical industry is crucial to protect human health and environment.
The Drug Regulatory Authority of Pakistan (DRAP) in 167th meeting directed to upload the National Hazardous Waste Management Policy 2022 on its website for the information and awareness of pharmaceutical industry and other stakeholders.
The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.
Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.
Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.
The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.
According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:
- To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
- To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
- To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
- To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
- To maintain pharmacovigilance records and documentation for at least 10 years.
“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”