ISLAMABAD, Dec 02 (APP): Special Assistant to Prime Minister on National Health Services, Regulation and Coordination Dr Faisal Sultan on Wednesday launched Drug Regulatory Authority of Pakistan’ s (DRAP) online application system to facilitate pharmaceutical manufacturers.
Addressing the launching ceremony, he said that it was evident from the launch of this online system that DRAP was moving towards complete transparency and efficiency in line with PM’s vision.
He said that we wanted operations of DRAP to become efficient in order to ensure availability of quality assured, safe and efficacious therapeutic goods in the country.
He said that this system would not only enhance the performance of operations but would also make sure that the regulatory body was working according to defined timelines.
Secretary National Health Services Aamir Ashraf Khawaja who is also chairman Policy Board of DRAP, said that this new system is the ultimate platform for enhancing DRAP’s efficiency through strict timelines and ease of doing business.
Asim Rauf, Chief Executive Officer of DRAP said that Pakistan Integrated Regulatory Information Management System (PIRIMS) was an online application management system which had been deployed for its testing in DRAP.
He said that PIRIMS online system would ensure online linkage of pharmaceutical companies and applicants with the authority.
This system is 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, he added.
He said that this online integrated system had all the features in line with best international regulatory practices. PIRIMS was intended to bring transparency, efficiency, and accountability of DRAP, he added.
Asim said that the software would facilitate pharmaceutical manufacturers to track and trace their applications for various licenses and registrations at DRAP.
He said that a complete record of every pharmaceutical manufacturer would 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.
PIRIMS was developed by DRAP in collaboration with United States Agency for International Development (USAID) Promoting Quality of Medicine Pulse (PQM+) Program.
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.
Stakeholders like Pakistan Pharmaceutical Manufacturers Association (PPMA) and Pharma Bureau were also invited to attend the ceremony.