Last Updated on May 9, 2023
Public consultation enables organizations to consider views and ideas from the citizens and relevant stakeholders during the development of new regulatory mechanisms, either through the enactment of new rules and policies or changes to existing ones or by the development and revision of regulatory guidelines which provide technical assistance and support implementation of best practices. We are committed to developing a regulatory framework in a clear, and transparent manner, that is in accordance with the harmonized best regulatory practice.
Inviting Public Comments
DRAP also seeks comments from the 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 the public. Stakeholders are requested to thoroughly review these documents and submit their suggestions/ corrections/ comments before the specified closing dates.
|Title||Doc Type||Start Date for Consultation||Closing Date for Consultation|
|Draft Guidance Document for Submission of Application on Form 5F (CTD) for Registration of Biological Drug Products for Human Use||Guidelines||09-May-2023||31-May-2023||View draft|
|Patient Information Leaflet (PIL) Guidelines (Draft)||Guidelines||05-May-2023||26-May-2023||View draft|
|Draft of Guidelines on the Lot Release of Biological Drugs||Guidelines||05-May-2023||26-May-2023||View draft|
|Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products||Guidelines||27-Mar-2023||17-Apr-2023||View draft|
|Draft Guidelines on Good Manufacturing Practice||Guidelines||05-Jan-2023||20-Jan-2023||View draft|
|Draft Therapeutic Goods (Federal Inspectors, Laboratories and Federal Government Analysts) Rules, 2022||Rules||24-Nov-2022||09-Dec-2022||View draft|
|Draft Therapeutic Goods (Advertisement) Rules, 2022||Rules||21-Nov-2022||06-Dec-2022||View draft|
|National Pharmacovigilance System (Edition 02)||Guidelines||24-Aug-2022||13-Sep-2022||View draft|
|Amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976||Rules||11-June-2022||27-June-2022||View draft|
|Guidelines on High Alert Medication Management||Guidelines||16-June-2022||08-July-2022||View draft|
|Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products||Guidelines||28-May-2022||16-June-2022||View draft|
|Guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)||Guidelines||18-May-2022||06-June-2022||View draft|
|Guidelines on Pharmacovigilance for Public Health Programs (PHPs)||Guidelines||23-Apr-2022||18-May-2022||View draft|
|Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products||Guidelines||15-Apr-2022||11-May-2022||View draft|
|Guidelines on Labelling and Packaging of Drug Products||Guidelines||15-Apr-2022||11-May-2022||View draft|
|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?
Being National Regulatory Authority, DRAP notifies rules that establish or modify the way to regulate pharmaceutical drugs, biological, medical devices, alternative medicines, and Health & OTC products. These rules may have a considerable impact on the nation’s health, industries, and economy. These rules are developed with inputs from stakeholders and the 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 the 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 are presented before the DRAP Authority in its meeting, and after the approval of DRAP Authority, these draft rules or amendments are published on the website of DRAP for open consultation soliciting comments from stakeholders and the public within a specified timeline.
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 considered for preparation of the final draft. These comments and the final draft are presented before the DRAP Authority’s 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 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 a notification for publication in the Official Gazette of Pakistan in the form of an 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 the public with the aim to interpret laws, rules, or policies and provide 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 cover the processing steps, formats, contents, and evaluation or approval process.
For the development of guidelines on a regulatory issue, the first step is the selection of a regulatory issue to which guidelines need to be developed. The relevant Division of DRAP selected the topic for developing 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 are 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.) oversight that regulatory issue. The recommended draft document is then circulated internally and/or externally seeking comments from stakeholders.
Draft Guidelines involving external stakeholders are also uploaded on the official website of DRAP for open consultation to seek comments from stakeholders and the 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 the 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.