Expedited approvals in Japan
Japan is one of the leading countries in Asia when it comes to obtaining marketing authorisations and conducting research.
Similar to other countries Japan has different mechanisms for expedited review which shortens the 12 month review period to 9 months. There are also orphan drug designation and breakthrough designation paths which allow promising new medicinal products to reach the Japanese market. Their conditional early approval and specific usage drugs allows novel drugs to be used in disease areas where there are no treatment alternatives.
Advanced therapies in Asia
This review discusses the latest trends in advanced therapies in Asia. It reviews the classification of advanced therapies and set the priorities in different countries in Asia.
Predicting the regulatory success in ASEAN markets
This review discusses the ASEAN countries and obtaining marketing authorisation in these countries. ASEAN comprises Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Viet Nam. The authors comment on the challenges in submitting application in these countries who while having similar regulations actually have different country requirements. Considering that the market in the countries is relatively small it makes in more challenging for pharmaceutical companies to justify the costs of perusing these markets.
