Pakistan, US launch innovative platform to evaluate safety and effectiveness of new medicines, improve health security

120320204

Islamabad: The Drug Regulatory Authority of Pakistan (DRAP), in partnership with the U.S. government, launched an innovative online platform that will enable the Government of Pakistan to more quickly and effectively evaluate the safety and effectiveness of medicine, leading to greater health security in the country.

The Government of Pakistan and the United States, through the United States Agency for International Development (USAID), worked together to create the platform to comply with international pharmaceutical standards.

The platform, called the Pakistan Integrated Regulatory Information Management System (PIRIMS), will integrate the registration, inspection, licensing, and monitoring of approved medicines. 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. This partnership will allow Pakistan to increase its participation in the international pharmaceutical market 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.

“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. “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.”