Orphan Drugs in Asia 2008

This report reviews the orphan drug regulations in countries throughout Asia and discusses various business issues associated with the registration of an orphan drug. The research, development, and marketing of drugs for rare diseases is not always financially beneficial for pharmaceutical companies, so they are generally reluctant to develop and market them under "standard" conditions and requirements. As a result, some countries have implemented regulations specifically for pharmaceuticals used to treat rare diseases, termed "orphan drugs." Several Asian nations have developed orphan drug legislation. Orphan drug laws in Asia may benefit companies; however, each country has specific registration requirements that can pose significant challenges. This report will address these country-specific regulations and provide a list of approved orphan drugs and orphan drug associations in Asian countries.