Rare disease care across Asia is advancing on two fronts: faster regulatory pathways for orphan drugs, and slow-building efforts to fund and diagnose the roughly 258 million people in Asia living with rare conditions. China’s revised Drug Administration Law implementing rules, effective May 15, 2026, granted market exclusivity to orphan drugs for the first time (up to seven years) alongside data exclusivity protections and expedited review pathways. The country’s national health insurance catalog was also expanded in 2026 to cover more rare-disease treatments.
Other countries are working to shorten the years-long diagnostic delays that patients typically face. Taiwan and Indonesia have both cut orphan drug review timelines. India has removed import testing barriers and added customs exemptions for select rare-disease medicines. Several Asian countries are expanding newborn screening and genomic diagnostic tools to catch problematic medical conditions earlier.
Progress for rare diseases is far more uneven in Southeast Asia. Singapore remains the region’s leader, having built a dedicated Rare Disease Fund since 2019, while the Philippines’ 2016 Rare Diseases Act has struggled with insufficient and even shrinking funding. Malaysia only published its first national rare disease policy in August 2025. Similarly, Vietnam only released its first National Action Plan for Rare Disease Management this past year.