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Online System for Pharma Manufacturers to be Launched

The Drug Regulatory Authority of Pakistan (DRAP) is all set to launch an online application management system for facilitation of pharmaceutical firms on November 2.

The Pakistan Integrated Regulatory Information Management System (PIRIMS) is an online application management system which has been deployed for testing in DRAP. Trainings have been conducted of DRAP’s assessors and inspectors on PIRIMS in the first phase.

Addressing the participants of a training session on PIRIMS, the Chief Executive Officer of DRAP said, the system will enable online linkage of pharmaceutical companies and applicants with DRAP.

PIRIMS links the functions of licensing, registration, inspection, post market surveillance and pharmacovigilance on one platform. Besides enhancing the efficiency of DRAP’s operations, the system has been designed to monitor performance of DRAP’s officers and staff. This system has all the features in line with best international regulatory practices.

PIRIMS is intended to bring transparency, efficiency, and accountability of DRAP. The software will facilitate pharmaceutical manufacturers to track and trace their applications for various licenses and registrations at DRAP. A complete record of every pharmaceutical manufacturer will be maintained by this system.

In the second phase, a comprehensive training session will be arranged for pharmaceutical manufacturers for submission of applications through PIRIMS. Applicants will be able to see the progress made on their requests in real time throughout the application lifecycle. Accordingly, regulatory correspondence related to shortcomings will also be done electronically.

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