Pakistan

DRAP launches online application system for pharma manufacturers

DRAP online system

Drug Regulatory Authority of Pakistan (DRAP) has launched the Pakistan Integrated Regulatory Information Management System (Pirims) – an innovative online application platform to enable the government to efficiently evaluate the safety and effectiveness of medicines

DRAP and the American government have jointly developed and introduced the online platform for an appropriate and integrated system of pharmaceutical manufacturing and marketing.

The platform has been formed jointly by the government of Pakistan and USAID so that the medicine manufacturing in Pakistan may go with international standards.

Read more: DRAP slashes price of FDA approved COVID-19 drug Remdesivir

The platform which has been given the title of “Pakistan Integrated Regulatory Management System” will integrate licensing, registration, inspection and pharmacovigilance activities and provide a platform to the pharmaceutical industry for the submission of applications, regulatory correspondence and feedback/complaint mechanism to address problems, faced by applicants.

In past, the process of registration of any medicine involved many years and also a lot of money but now the time period and money involved, both have been reduced and as such, the pharmaceutical companies would be able to market the medicines in time and at a reasonable price.

The automated system will also enable DRAP to switch over to a paperless working environment. This platform will enable Pakistan to move towards becoming part of the third level of Global Benchmarking (GBT) tool which has been by set World Health Organization (WHO) to inspect the pharmaceutical manufacturing standard of any country.

The DRAP will then also be able to apply for the membership of an International organization for pharmaceutical inspection.

The Director of USAID, Michel Nehabass said on the occasion that they are happy to coordinate with Pakistan in this regard. Pakistan already has the capability of international level pharmaceutical manufacturing and that would open new ways of investing in the pharmaceutical industry.

This is a praiseworthy step towards accountability, transparency, efficiency, and stakeholder engagement.

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