In October 2024, Singapore’s Health Sciences Authority (HSA) updated its Guidance on Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers. From October 1, 2024, evidence demonstrating GMP compliance is mandatory for all new or generic drug applications and minor variations involving new DS manufacturers. This requirement follows a one-year grace period and does not apply to existing registered products, unless a new manufacturer/site is added. Only GMP certificates issued by Pharmaceutical Inspection Co-operation Scheme authorities are accepted.
The Ministry of Health and Welfare of Korea has planned reforms to its drug reimbursement and pricing regulations to make more room for negotiations over innovative treatments. The proposal, open to public consultation until December 16, 2024, introduces two new risk-sharing agreements (RSAs): one with a fixed cost for an initial treatment refund and another with a performance-based refund. These join four existing RSA mechanisms that support faster reimbursement of high-cost, high-uncertainty treatments. Other changes include new cost-effectiveness evaluation criteria and incentives for essential drugs using locally produced materials. This reform would constitute a policy turn toward being more accommodating and spurring domestic pharmaceutical development.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.