Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-
- SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017
- Notification: Applications for Registration of Multiple Strength and Volume Drugs (Pharmaceutical) on Form-5F