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Recent update in legislation for therapeutic goods in Pakistan

 Muhammad Ayub Naveed

 The Drug Regulatory Authority of Pakistan Act, 2012 was promulgated on 13th November, 2012 by the Parliament for the establishment of Drug Regulatory Authority of Pakistan to regulate the manufacture, import, export, storage, distribution and sale of therapeutic goods including drugs, alternative medicines, and medical devices, biological and other related products as may be notified by the Authority.  For this purpose Medical Devices Rules, 2017 were notified on 16th January, 2018 with phase-wise regulation over a span of 1 to 2 years for four risk classes. All medical device shall now be regulated according to these new rules. Bio Safety Rules, 2017 has been notified for conducting Clinical trials and establishlishing CROs. Alternative Medicines Enlistment Rules, 2014 is entering its second phase of regulation. DRAP has adopted Common Technical Documentation (CTD) Dossier for registration of pharmaceutical products.