On July 31, 2025, Taiwan’s Ministry of Health announced a phased plan to digitize drug package inserts, moving everything to a digital and paperless format. By December 31, 2025, all prescription and non-prescription drug inserts must be structured electronically and uploaded to the Drug Package Insert Inquiry Platform. Digital format must be fully implemented by this deadline. QR codes with links to the electronic insert will replace paper inserts. Drug companies will be required to notify suppliers before the transition and provide printed copies upon request.
In July, Vietnam issued Circular 30, which replaced Circular No. 11/2018/TT-BYT and its amendments with respect to drug quality standards. With respect to quality, drugs in Vietnam need to meet the Vietnamese Pharmacopoeia or the US, EU, British, Japanese, or International Pharmacopoeia. Under the new Circular, biologics and vaccines now must be tested locally before being put on the market. Furthermore, the new Circular outlines for local, provincial, and municipal health departments, the specific requirements for these officials to deal with drugs that are not compliant. If a drug violates the quality standards, local officials can initiate a recall without getting the Drug Administration of Vietnam’s approval.
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.