SROs
S.R.O. 1067(I)12023: Schedule of Charges for GMP Certificate and Panel Inspection
SRO.769(I)/2023 dated 23rd June, 2023: Fixation of Maximum Retail Price (MRP) of Drugs and Biologicals
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 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
SRO 595(I)/2023: Maximum Retail Price of Drugs and Biologicals Under CPI.
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: –