DRAP launches online application system to ensure quality and transparency
The Drug Regulatory Authority of Pakistan (DRAP) has launched an online application management system to
The Drug Regulatory Authority of Pakistan (DRAP) has launched an online application management system to facilitate pharmaceutical manufacturers and ensure accountability, quality and transparency.
The online system was launched by the Special Assistant to Prime Minister (SAPM) on National Health Services, Regulation and Coordination, Dr Faisal Sultan on Wednesday.
The system, named Pakistan Integrated Regulatory Information Management System (PIRIMS), has been developed by the regulatory authority with the support of United States Agency for International Development (USAID) and will help to ensure online linkage of pharmaceutical companies and applicants with DRAP.
DRAP has developed the system keeping in view the 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.
SAPM Faisal Sultan while addressing the launch ceremony of PIRIMS said that the introduction of the online system is a proof that DRAP is heading towards complete transparency and efficiency in line with the Prime Minister Imran Khan’s vision.
Faisal said that it was the duty of the regulator to ensure quality and safety of medicines in Pakistan, adding that, “We cannot ensure quality and affordable medicines as long as we do not make things easy for the industry. Now companies will be able to trace the applications and ultimately the general public will be the beneficiary as they will get quality medicines”.
The new online system will allow the applicants to apply and view the real-time progress of their requests throughout the application life cycle, without having to visit the office.
The online system will act as a one stop shop for all the companies as it links the functions of licensing, registration, inspection, post market surveillance and pharmacovigilance in a single platform.
Moreover, the representative of the companies can keep track of their applications for registration and licensing functions of therapeutic goods and manufacturers with realistic timelines.