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.
Legislation
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)
Drugs Research Rules 1978 (Amended)
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.