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.
China is quickly catching up with the rest of the world in the pharma sprint, with regulators greenlighting a record 43 new innovative medicines in the first half of 2025, a year-on-year increase of 59%. Most of the newly approved medicines target cancer, metabolic, and immune diseases. The National Medical Products Administration (NMPA) attributes this significant boost to sustained regulatory reform, which has resulted in industry’s increased confidence in making risky R&D drug investments.
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.