General
Approved Content Weightages for Drug Regulatory Authority Government of Pakistan Adv.No.02/2024
DRAP Newsletter: Volume 03-Issue -II, November, 2024
The Drug Regulatory Authority of Pakistan (DRAP) has released a new issue of its quarterly newsletter, featuring several key updates and initiatives. DRAP has extended the scope of its Industry E-Reporting System for Adverse Drug Reactions to all registration holders, following a successful pilot project. The newsletter details recent actions on the promotion of clinical trials regulatory oversight, the stakeholder queries management system, and interprovincial coordination for the implementation of the Institutional Development Plan as per WHO recommendations. Additionally, the newsletter covers ongoing efforts to enhance public health and safety, including increased surveillance and regulatory actions to ensure the quality and safety of therapeutic goods.
Career Opportunities: Applications are invited for Various Positions in DRAP
The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)
DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.
Details of Vacant Positions advertised are as below.
Advisory: Medication Safety and Supply Chain Integrity for Procurement of Therapeutic Goods
Submission of Replies against Deferred Form-5/5A Applications of Human Drugs
In its 339th Meeting, convened from August 6-8, 2024, the Registration Board has issued a directive that all applicants should submit clarifications or replies for their deferred Form-5/5A applications by December 31, 2024. It is imperative to note that any submissions received after this deadline will not be considered, and will be be classified as disposed of, necessitating the submission of a new application on Form 5F.
This initiative is designed to enhance the efficiency of the registration process and ensure strict adherence to current regulatory standards. This directive is in accordance with the implementation of the Form 5F (CTD) format for drug registration, effective March 31, 2019, which requires that all applications be evaluated based on the updated Form 5F data guidelines.
Consideration of Form-5/5D Applications for Registration of Drug Products: Stability Data Submitted Before 30th June, 2023
List of applications submitted by the firms for provisional enlistment of H & OTC products received from 01st January 2023 to 31st December 2023 (Nutraceutical, Herbal, Homeo)
Caution Regarding Fake Emails Impersonating DRAP Officials
It has come to our attention that some individuals are receiving fraudulent emails impersonating officials of the Drug Regulatory Authority of Pakistan (DRAP). Please be advised that all official DRAP correspondence comes from email addresses ending with @dra.gov.pk.
Stakeholders and the public are urged to remain vigilant and verify the authenticity of any communication. If in doubt, kindly contact DRAP through official channels.
Thank you for your attention to this matter.
Drug Regulatory Authority of Pakistan
Switch over from Web Based One Customs (WEBOC) to Pakistan Single Window (PSW) for submission and issuance of all types Drug Import Licenses (DILs) and issuance of electronic release orders through PSW’s Single Declaration (SD) system.
We are pleased to announce that, effective October 8, 2024, the clearance of commercial imports (HC type) of all commodities (Drugs) requiring a Drug Import License (DIL) mandated by the Drug Regulatory Authority of Pakistan (DRAP) being imported at customs stations of Peshawar and Islamabad are being switched from WeBOC to PSW system. All the DRAP-related commodities (Drugs) will be completely shifted over to PSW, and clearance will be subject to the electronic issuance of a Release Order by DRAP through the filing of a Single Declaration (SD) on all customs stations located in Peshawar and Islamabad.
All traders/importers engaged in the import of these commodities falling under the purview of DRAP are informed to file Single Declaration (Imports) through PSW System for issuance of electronic Release Order from DRAP and Customs clearance of their import consignments w.e.f. 08th October 2024.