SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017

The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-

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:-

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, copied at, 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.

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: –