The availability of generic medication is an important

issue in the ASEAN regions. The regulatory requirements

of various countries of the world vary from each other.

Therefore, it is challenging for the companies to develop a

single drug which can be simultaneously submitted in all the

countries for approval. The regulatory strategy for product

development has to be established before commencement

of developmental work in order to avoid major surprises

after submission of the application. The JSS College team

with Balamuralidhara V. at the Regulatory Affairs Group,

Department of Pharmaceutics, JSS College of Pharmacy

provides an overview on Singapore and Thailand’s marketing

authorisation.