DRAP issued Guidelines for Public Health Programs (PHPs) to promote Pharmacovigilance activities and enhancing collaboration with National Pharmacovigilance Centre, DRAP.

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.

The key objectives of pharmacovigilance activities in public health programs are:-

  1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
  2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
  3. To encourage the safe, rational and more effective use of therapeutic goods.

This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

DRAP published the draft of this guidelines on its website on 23rd April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidelines on the pharmacovigilance activities in the public health programs are finalized. Nevertheless, anyone can still furnish his/her comments on the guidelines using our comments submissions methods for consideration in the future editions of the document.

Please click to view the document, GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES

DRAP issues guidance on the submissions of Clinical Trials Applications

The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document provides general guidance to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline on the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials.

These guidelines will assist sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.

These guidelines explains the procedures for filing applications of clinical trials and provides an insight on the steps to be followed by the applicants. As per DRAP Act, 2012 and Drug Act, 1976 it is required that all the therapeutic goods marketed in Pakistan must have a valid authorization / registration with the Drug Regulatory Authority of Pakistan (DRAP), and any clinical trials using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.

DRAP published the draft of this guidance document on its website on 8th April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidance document on the clinical trial applications is finalized. Nevertheless, anyone can still furnish his/her comments on the guidance documents using our comments submissions methods for consideration in the future editions of the document.

Please click here to view the Guidance on Clinical Trials Applications

DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country

DRAP has a regulatory oversight on import and export of all type of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws, and refuses the entry or exit of any therapeutic good in case of noncompliance to the regulatory requirements.

“Import and export of any therapeutic goods prohibited under Rule 23 of the Drugs Act 1976 and Schedule II of the DRAP Act 2012 are punishable under Rule 27 of the Drugs Act 1976 and Schedule III of the DRAP Act, 2012”

These regulatory controls are applied to prevent the infiltration of substandard and suspected falsified medicine into the supply system and to assure the access to standard quality therapeutic goods. This guidance document will elaborate the requirements, procedures for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. It covers the both import and export of therapeutic goods for commercial and non-commercial purposes, and also provides guidance on determination of the eligibility of importers and exporters.

Please click to access the final guidance document on Import and Export of Therapeutic Goods

The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.

For more information on regulatory guidelines issued by DRAP, please navigate to our section on “Regulatory Guidelines

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