Drug Regulatory Authority of Pakistan, on the recommendations of the Registration Board has issued guidance for submitting applications for registration of pharmaceutical product with multiple strengths and different fill volumes. The Notification issued in this regard is as under:-
Notifications
SRO 678(I)/2023 Amendments in the Drug Pricing Policy-2018.
SRO.649(I)/2023: MRP fixation of Cardiac Stents
Drug Regulatory Authority of Pakistan with approval of the Federal Government, in exercising its powers conferred by subclause (vii) of clause (c) of section 7 of the Drug Regulatory Authority of Pakistan Act2012 (XXI of 2012) readwith section 1 2 of the Drugs Act, 197 6 (XXXI of 197 6) has notified the maximum retail prices of cardiac stents as specified hereunder:-
SRO 620(I)/2023: Fixation of Maximum Retail Price of Cardiac Stents
Stakeholders’ Comments are invited on the Draft Guidelines on Patient Information Leaflet
The Patient Information Leaflet (PIL) provides essential information to patients and caregivers on the use of drug products ensuring their safety, efficacy, and quality. It describes the information for patients that ensures the safe and effective use of medicine under most circumstances. The PIL is a document that is updated as new data emerges related to drug product safety, efficacy, and quality or use. The registration/market authorization holder is responsible shall supply any new information without delay which may require the variation of the marketing authorization/registration including the revision of PIL.
The guideline is intended to provide supportive information for preparing a Patient Information Leaflet (PIL) for registration/market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products, and Biosimilars. This guideline provides advice on the principles of presenting information in the PIL.
This draft guideline is uploaded on the official website of DRAP dated 5th May 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit DRAP website or click here. Comments and suggestions can be emailed to haseeb.tariq∂dra.gov.pk, copied at addl-dir.pe.reg∂dra.gov.pk, or posted at the mailing address, Director, Pharmaceutical Evaluation & Registration, Drug Regulatory Authority of Pakistan, 4th-floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.
GCP_Inspectorate_Notifications
DRAP issued Consolidated Notification for Regulatory Fees
Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂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. Further information on comments submission can be accessed on this link.
Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Licensing, Registering & Advertising) Rules 1976 and the Medical Device Rules, 2017
The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are herby notified seeking comments from stakeholder.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂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. Further information on comments submission can be accessed on this link.
Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing
Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”
Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:
“The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”
Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.