Comparative Regulatory Account on Post Approval Compliance of Us, South Africa and GCC Countries

Abstract

The study gives the idea of comparative view of various post approval compliance activities of semi-regulated regulatory authorities of South Africa, Saudi Arabia and United Arab Emirates with regulated USFDA authority. The study involves regulatory view on post approval change management, post approval changes, annual reports, renewals of dossier and post marketing safety surveillance i.e periodic safety update reports. USFDA is stringent regulatory authority and have well established guidelines for every activity. In June 2017, the MCC has upgraded to the SAHPRA. SAHPRA has recently moved towards electronic submission and updating their guideline trying to be a stringent regulatory authority. GCC countries have reference of European guidelines. This study mentioned the post approval submission, annual report and PADER report which give the practical view of submission report. And study gives the idea about requirements to fulfill and documents required to submit while submitting the application. This study gives overview of USFDA, SAHPRA, SFDA and MOHAP regulations in one study. USFDA is founder member of ICH committee and SAHPRA, SFDA and MOHAP follows ICH guidelines for quality and safety. But still every regulatory authority has their own guideline for regulatory activities.