How Generic Drugs are Registered in Europe, United Kingdom, Australia and New Zealand? - A Drug Regulatory Perspective

Abstract

The present study describes the process of regulatory submission and generic drug registration in Europe, the UK, Australia, and New Zealand. The information and data for the compilation of the present review has been obtained from the relevant journals and from the official websites of respective drug regulatory authorities of Europe, the UK, Australia, and New Zealand. The generic drug approval process differs from one country to another. Europe follows multiple registration processes and the applicant decides the pathway based on the product category while the other three countries stick to a single registration process. All four countries follow the electronic CTD format for submitting the regulatory documents which allows the evaluation process more convenient and easier. The British Pharmacopoeia is a single reference guide for the quality control of medicines in all four countries under this study. From this study, it was concluded that in Europe and UK it takes about 12 months for dossier review for the approval of the generic drug. TGA of Australia takes approximately 11 months of timeline for generic drug approval whereas; MEDSAFE of New Zealand takes just 200 calendar days for generic drug registration which is quicker as compared to the other three countries.

Keywords: CTD; EMA; MHRA; TGA; MEDSAFE