Product post Approvel Change Managet : Comparative Study of Europe South Africa & Brazill

Abstract

The present study includes overview of regulatory agencies of all three countries i.e. Europe (EMA), South Africa (MCC) & Brazil (ANVISA) along with their various types of post approval changes & the approval process. European Medicine Agency (EMA) has well established regulatory guidelines for a medicine to be authorized. Whereas South Africa (MCC) & Brazil (ANVISA) are the potential growing market which widely follows European guidelines which are based on ICH guidelines for a product to get registered. Europe follows eCTD format for a product to get registered, while South Africa has made mandatory after 1 June 2016 to convert older dossier to CTD format by allowing easier access for review and comment. Brazil also follows its own national format (i.e. paper format). The study includes comparative analysis of post approval changes for all three regulatory authorities. Europe has its own variation guideline document which includes different categories for a change in the medicine and sets out detailed requirements and conditions for that change to get assessed. South Africa has 2.08 Amendments document been prepared to serve as a recommendation to the holder of a certificate of registration wishing to submit applications for amendment of a registration dossier of a medicine, whereas Brazil has RESOLUTIONNº 73 document which provides guidelines for post registration changes. Key words:-EMA, MCC, ANVISA, Post approval changes, CTD, eCTD