New platform launched to evaluate safety of medicines

Islamabad : The Drug Regulatory Authority of Pakistan (DRAP), in partnership with the United States Agency for International Development (USAID), launched an innovative online platform Wednesday that will enable quick and effective evaluation of the safety and effectiveness of medicines, leading to greater health security in Pakistan.

The Prime Minister’s Special Assistant on Health Dr. Faisal Sultan inaugurated the system as chief guest at a ceremony also attended by Secretary Health Aamir Ashraf Khawaja, DRAP’s Chief Executive Officer Asim Rauf, officials from USAID, and stakeholders from the pharmaceutical sector, among others.

The ‘Pakistan Integrated Regulatory Information Management System (PIRIMS),’ as it is named, will facilitate pharmaceutical firms by integrating the registration, inspection, licensing, and monitoring of approved medicines on one platform compliant with international pharmaceutical standards. 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.

With PIRIMS, regulators can more quickly and effectively monitor medicines in the development and approval processes, and pharmaceutical companies will be able to more quickly and easily apply for permission to produce a medicine. In the past, it could take several years and cost millions of rupees for a pharmaceutical company to register a drug; that time and cost will now be greatly reduced, allowing Pakistani companies to bring safe, effective medicines to market more quickly and less expensively.

Addressing the gathering, Dr. Faisal said, the launch of this system indicates that DRAP is moving towards transparency in line with the PM’s vision. “We want the operations of DRAP to become efficient in order to ensure availability of quality assured, safe and efficacious therapeutic goods. PIRIMS will make sure that the regulatory body is working according to defined timelines,” he stated.

Aamir Khawaja, who is also Chairman of the Policy Board of DRAP, termed PIRIMS as the ultimate platform for enhancing DRAP’s efficiency and monitoring the performance of its officers and staff.

“We are pleased to partner with the government of Pakistan to ensure this system complies with international standards, strengthening health services across the country,” said USAID Deputy Mission Director Michael Nehrbass, who participated virtually. “Pakistan already has one of the best laboratory networks in the region as a result of our work together, and this new capability will likely lead to further development and international investment in the pharmaceutical industry,” Michael added.

The partnership will allow Pakistan to increase its participation in the international community and apply for Level Three Compliance with the World Health Organization’s Global Benchmarking Tool, a globally accepted model to evaluate the maturity of a country’s regulatory framework. It will also allow DRAP to apply for membership in the Pharmaceutical Inspection Co-operation Scheme, an international cooperative to standardize pharmaceutical standards.