Publications
DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022
Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.
The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21st November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022
Minutes of 1st Meeting of Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on 12-October, 2022
1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 12th of October, 2022. The minutes of meeting are attached hereunder:-
Decisions of 50th meeting of Medial Device Board (Deficiency letters Local/Import)
Minutes of 321st meeting of Registration Board held on 20th to 22nd September, 2022
The Drug Registration Board convened its 321st meeting on 20th – 22nd September, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
Decisions of 49th meeting of Medial Device Board (Deficiency letters Local/Import)
110th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
108th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 108th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 22nd June, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.
107th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents
The 107th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2022. The detail of applications which required further information /clarification and documentation is attached hereunder for information by all stakeholders.