Notifications
Model List of National Essential Medicines (2025) – Notification Dated 20-10-2025
Product Specification of Mecobalamin / Methylcobalamin Tablet
Revised Regulatory Fee for Therapeutic Goods
Notification of draft amendments in the Drugs (Labelling and Packing) Rules 1986
Draft amendments to the Drugs (Labelling and Packing) Rules, 1986, have been published for public information. Comments or suggestions, if any, may be forwarded to director.legal∂dra.gov.pk within seven days of the publication of this notification.
Amendment in the Drugs (Licensing, Registering and Advertising) Rules, 1976 (S.R.O 1047(I)/2025)
Amendment in Medical Devices Rules, 2017 (S.R.O 1049(I)/2025)
Amended Drug Pricing Policy 2018
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.
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.