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Pakistan set for new regulatory system:

This article was originally published in Clinica

Executive Summary

Pakistan is in the process of approving a new, autonomous agency that will regulate medical devices, to be named the Drug Regulatory Authority. Prime Minister Shaukat Aziz approved the establishment of the DRA at a meeting of senior health officials this month. Designed to streamline the registration of medical products, its responsibilities would include: the enforcement of regulatory laws; accessibility to safe and effective medicines and devices; and rationalisation of pricing. The draft Drug Regulatory Authority Act has been finalised in consultation with stakeholders. Registration documents required for establishing the new authority are yet to be presented to the cabinet for approval.

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