Last Updated on August 24, 2022
Public consultation enables organizations to consider views and ideas from the citizens and relevant stakeholders during the development of new regulatory mechanisms, either through enactment of new rules and policies or changes to existing one, or by the development and revision of regulatory guidelines which provide technical assistance and support implementation of best practices. We are committed to developing regulatory framework in a clear, and transparent manner, that is in accordance with the harmonized best regulatory practice.
Invitation for public comments
DRAP also seek comments from public and relevant stakeholders to identify their needs and expectation, to gather deep insights on proposals, in order to strengthen the regulatory decision making process, and to comply with the international best practices. We encourage the involvement of all relevant stakeholders in our document making process. Once finalized, these documents may have an impact on/ are to be implemented on the stakeholders which may include the therapeutic goods industry, healthcare-professionals, patients and/or public. Stakeholders are requested to thoroughly review these documents and submit their suggestions/ corrections/ comments before the specified closing dates.
|Sr.||Title||Doc Type||Start Date for Consultation||Closing Date for Consultation|
|1||National Pharmacovigilance System (Edition 02)||Guidelines||24-Aug-2022||13-Sep-2022||View draft|
|2||Amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976||Rules||11-June-2022||27-June-2022||View draft|
|3||Guidelines on High Alert Medication Management||Guidelines||16-June-2022||08-July-2022||View draft|
|4||Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products||Guidelines||28-May-2022||16-June-2022||View draft|
|5||Guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)||Guidelines||18-May-2022||06-June-2022||View draft|
|6||Guidelines on Pharmacovigilance for Public Health Programs (PHPs)||Guidelines||23-Apr-2022||18-May-2022||View draft|
|7||Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products||Guidelines||15-Apr-2022||11-May-2022||View draft|
|8||Guidelines on Labelling and Packaging of Drug Products||Guidelines||15-Apr-2022||11-May-2022||View draft|
|8||Guidelines for Clinical Trials Applications||Guidelines||08-Apr-2022||28-Apr-2022||View draft|
Related Content: How to submit comments on drafts documents
How new Rules are developed for Therapeutic Goods?
The DRAP, as a regulatory authority notifies rules that establish or modify the way to regulates pharmaceutical drugs, biological, medical devices, alternative medicines, and Health & OTC products. These rules may have considerable impact on the nation’s health, industries and economy. These rules are developed with the inputs from stakeholders and public, and anyone can participate in the rule making process by commenting on the draft rules published by the DRAP.
The Drug Regulatory Authority of Pakistan proposes new rules or amendments to the existing rules to the Federal Government for approval under Section 23 of DRAP Act, 2012. The process for development or amendments in the rules is initiated by the relevant Division of the DRAP / or the concerned technical expert Board or Committee. The drafts of the proposal is presented before the DRAP Authority in its meeting, and after the approval of DRAP Authority, these drafts rules or amendments are published on the website of DRAP for open consultation soliciting comments of stakeholders and public within a specified timelines.
The comments received from the stakeholders and public are tabulated against the relevant clauses of the draft legislation. These comments are carefully reviewed, evaluated and considers for preparation of the final draft. These comments and the final draft are presented before the DRAP Authority in its meeting. The DRAP Authority finalizes the draft and forwards the recommendation to M/o.NHS,R&C for onward approval from Federal Government. M/o.NHS,R&C also forwards the draft legislation to the the Law & Justice Division. These recommendations are then placed before the Cabinet Committee for Disposal of Legislative Cases (CCLC) and Federal Government for approval. After approval from Federal Government, the DRAP issues notification for publication in the Official Gazette of Pakistan in the form of SRO. The newly promulgated rules are also published on the official website of DRAP.
How DRAP develops Guidelines?
Generally, Guidelines and Guidance documents are developed for the industry, regulatory staff, healthcare professionals and public with the aim to interpret laws, rules, or policies and provides recommended best practices on regulatory issues. These guidance documents provide more specific details on regulatory issues which may relate to the design, manufacturing, labeling, advertisement and testing of therapeutic products, and may also covers the processing steps, formats, contents, and evaluation or approval process.
For development of guidelines on a regulatory issue, the first step is the selection of a regulatory issue to which guidelines needs to be developed. The relevant Division of DRAP selected the topic for development of a guideline and a draft document is formulated by the working group comprising members of the related Division of DRAP. The draft documents generated by the working group is critically reviewed by the Divisional Head or the Director of that Division, and presented before the technical expert Boards / Committee (Registration Board, Medical Device Board, etc.) oversighting that regulatory issue. The recommended draft document is then circulated internally and / or externally seeking comments of stakeholders.
Draft Guidelines involving external stakeholders are also uploaded on the official website of DRAP for open consultation to seek comments from stakeholders and public. The received comments are carefully reviewed and considered in the preparation of the final draft by the concerned Divisional head / Board / Committee, or the related Division. The final draft is then processed for the approval of DRAP Authority or the CEO, DRAP along with tabulated comments received from stakeholders. Final approved Guidelines involving external stakeholders, are uploaded on the official website of DRAP.