Writing in the December edition of DIA’s Global Forum magazine, Agnes Ho, Cindy Zen, and Tan Kwee Lan of Boehringer Ingelheim give an overview of the current regulatory framework for orphan drug registration in four ASEAN countries and what more could be done to improve it.
Regulatory authorities such as US FDA, EMA, and PMDA have had regulatory frameworks for orphan drugs (OD) in place for decades. Upon recognizing that their existing drug development and regulatory frameworks may not be suitable for rare disease (RD) therapeutic interventions, regulators in Singapore, Malaysia, Philippines, and Vietnam have also started to initiate regulatory reforms for OD registrations. This table illustrates the current state of these reforms.
*FDA and EMA grant periods of data exclusivity as an incentive to orphan drug sponsors.