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Pak-US platform to evaluate safety of new medicines

ISLAMABAD: DRAP, in partnership with the US govt, launched an innovative online platform that will enable the GoP to more quickly and effectively evaluate the safety and effectiveness of medicine, leading to greater health security in Pakistan.

The GoP and the US, through the 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 WHO’s Global Bench-marking Tool (an internationally 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.

USAID Deputy Mission Director Michael Nehrbass maintained: “We are pleased to partner with the Government of Pakistan to ensure this system complies with international standards, strengthening health services across the country.

“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.”

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M M Alam

M. M. Alam is a Pakistan-based working journalist since 1981. Karachi University faculty gold medalist Alam began his career four decades ago by writing for Dawn, Pakistan’s highest circulating English daily. He has worked for region’s leading publications, global aviation periodicals including Rotors (of USA) and vetted New York Times as permanent employee of daily Express Tribune. Alam regularly covers international aviation and defense-related events including Salon Du Bourget (France), Farnborough (United Kingdom), Dubai (UAE). Alam has reported thousands of events and interviewed hundreds of people in Pakistan, UAE, EU, UK and USA. Being Francophone Alam also coordinates with a number of French publications.