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Regulatory Updates

Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

Asad Ullah Drugs, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Implemenation letter of Industry e-reporting systemDownload

Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Asad Ullah Drugs

Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

It is hereby circulated for compliance and information of all stakeholders.

CIRCULAR-SmPC-PILDownload

Career Opportunities: Applications are invited for Various Positions in DRAP

Ijaz Mustafa Careers, General

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.

46×4-and-48×4-Ad-25-10-24Download

Submission of Replies against Deferred Form-5/5A Applications of Human Drugs

Ijaz Mustafa General

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.

submission-of-replyDownload

Caution Regarding Fake Emails Impersonating DRAP Officials

Yasir Mahmood General ,

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.

Ijaz Mustafa General

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.

SWITCH-OVER-TO-PSW-2-1Download