DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs.
All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained. It is further clarified that after the lapse of the due time for above-said activity, necessary regulatory fee may apply.
For further information and queries, Registration holders may contact Data Management Cell (DMC) of Pharmaceutical Evaluation & Registration Division through email (dmc∂dra.gov.pk) with regards to guidance for procedures and requirements etc.
Pakistan Integrated Regulatory Information Management System (PIRIMS)
PIRIMS enable the regulators and industry to communicate electronically for processing regulatory information related to licensing, registration, inspections procedures for pharmaceutical and biological drugs.