- Vietnam’s Ministry of Health presented significant amendments to the pharmaceutical law to the National Assembly in June 2024. The 2016 Pharmaceutical Law, which succeeded the 2005 law, initially provided a transparent legal foundation for the pharmaceutical industry and aligned with global standards. However, some aspects of the law have become outdated over the past eight years. The proposed revisions aim to ensure public access to quality, affordable medicines, resolve legal and institutional challenges, and guarantee medicine availability for disease prevention and emergencies. This new bill plans to streamline various pharmaceutical procedures to enhance accessibility for citizens and businesses. The revised law proposes a maximum nine-month period for reviewing new drugs and vaccines, provided they have evaluations from other stringent regulatory authorities. Additionally, the bill addresses the rise of e-commerce by adding regulations for online sales of medicines and banning pharmaceutical sales on social media.
- Given Japan’s drug lag which we have been reporting on over the last few years, one of their new drug policies is to increase the development of pediatric drugs. On July 1, the PMDA set up a consultation center for both pediatric and orphan drugs. The goal of this center is to further the development of orphan as well as pediatric drugs. The center will provide consultation sessions on pediatric drug development, related clinical trials, potential regulatory problems, etc.
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.
