Regulatory Comparision Study Between Europe and Australia for Generic Medicines with Special Focus on Filing Requirements, Pre-Approval and Post-Approval Processes

Abstract

Indian Pharmaceutical market is the most rapidly evolving market in the World. According to International monetary fund; world economic outlook, India had a GDP of 7.168% in 2015 and is the 15th fastest growing nation of the world. Indian pharmaceutical market have immense potential to generate revenue and is exploring different regions of the world to further branch its scope in terms of both generic and innovative medicines. The present study includes studying of regulatory agencies of two continents i.e. Australia and Europe for registration process, approval and post approval process of the generic medicine as per Europe and Australia requirements. European medicine agency (EMA) have well-established regulatory guidelines for a medicine to be authorized whereas Australia’s Therapeutic goods administration (TGA) is a potential market and widely follows European guidelines which are based on ICH guidelines for a medicine to get registered. Europe is a part of ICH and has made the eCTD submission mandatory. Australia following the footsteps of Europe changed its submission from NeeS/paper to eCTD submission. The study includes comparative analysis of registration requirements in Europe and Australia, understanding the different regulatory processes starting from filing requirements to life cycle management of the product. The study is a systematic approach to, understand both regulatory authority’s administrative and legal aspects; to identify specific filing requirements of both countries; compilation of data, preparation of dossier in eCTD and post approval changes. Europe has four pathways to offer marketing authorization to the applicant and Australia has one single way to register a medicine. Australia and Europe have major differences in requirements of module 1 of eCTD; the administrative section. The lifecycle management of medicines in Europe is easy to get assessed compared to Australia. Europe has variation guidelines which includes different categories for a change in the medicine and sets out detailed requirements and conditions for that change to get assessed. In Australia the life cycle management is comparatively difficult; reason being it’s difficult to interpret variation guidelines for post approval changes.