ISLAMABAD-Drugs Regulatory Authority of Pakistan (DRAP) on Wednesday launched online application system for facilitation of pharmaceutical manufacturers.
Spokesperson of Drug Regulatory Authority of Pakistan told that DRAP launched an online application management system for facilitation of pharmaceutical firms.
Pakistan Integrated Regulatory Information Management System (PIRIMS) is an online application management system which has been deployed for its testing in DRAP. While addressing to the officers of DRAP during launching ceremony of PIRIMS, SAPM Dr. Faisal Sultan said that it is evident from the launch of this online system that DRAP is moving towards complete transparency and efficiency in line with PM’s vision.
He said that we want operations of DRAP to become efficient in order to ensure availability of quality assured, safe and efficacious therapeutic goods in the country. PIRIMS will not only enhance the performance of operations but will also ensure that the regulatory body is working according to defined timelines. Secretary Health Aamir Ashraf Khawaja who is also Chairman Policy Board of DRAP, said that PIRIMS is the ultimate platform for enhancing DRAP’s efficiency through strict timelines and ease of doing business.
Officials from Ministry of National Health Services, Regulation & Coordination were also present in the launching ceremony. Stakeholders like Pakistan Pharmaceutical Manufacturers Association (PPMA) and Pharma Bureau were also invited to attend the ceremony. PIRIMS was developed by DRAP in collaboration with United States Agency for International Development (USAID) Promoting Quality of Medicine Pulse (PQM+) Programme. The online application management system links the functions of licensing, registration, inspection, post market surveillance and pharmacovigilance on one platform.
Applicants can keep track of their applications for registration and licensing functions of therapeutic goods and manufacturers with realistic timelines. The software is developed according to international standards of data and supports Common Technical Document (CTD) submission, online inspection reporting of pharmaceutical firms, quality assurance and market surveillance of medicines and adverse drug reaction reporting. Asim Rauf, Chief Executive Officer of DRAP said that PIRIMS online system will ensure online linkage of pharmaceutical companies and applicants with the authority.
This system is of paramount importance for improving the functions of DRAP and will promote transparency. Besides enhancing the efficiency of DRAP’s operation, this system has been designed to monitor performance of DRAP’s officers and staff. He informed the participants that PIRIMS was developed during the last two years and multiple tests runs have been performed on it. Trainings were conducted of DRAP’s assessors and inspectors on PIRIMS as well as pharmaceutical companies in the first phase. 
This online integrated 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. Applicants will now be able to see the progress made on their requests in real time throughout the application life cycle. Accordingly, regulatory correspondence related to shortcomings will also be performed electronically.