Current Edition

Comparison of Marketing Authorisation and its Requirements for Brunei Darussalam and Indonesia

The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for companies to develop a single drug which can be simultaneously submitted in all the countries for approval. G. Ravi, Pharmaceutical Quality Assurance, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, talks about regulatory strategies, product developments, and the comparison of marketing authorisation and its requirements for Brunei Darussalam and Indonesia.