Late last year, Vietnam issued a new law updating and augmenting their 2016 Law on Pharmacy. The updated drug law will simplify some drug regulations and begin on July 1, 2025. On the product registration front, if the drug has been approved by another advanced country, the review period will only be 9 months, as opposed to 12 months. Renewal drug applications will be reduced to 3 documents, including the application form, CPP for the imported drug, and a current report on the drug’s safety and efficacy. In addition, for drug renewal, if the drug product (DP) or drug substance (DS) has expired but a renewal has been submitted, the DP or DS can still be sold in Vietnam until it is renewed or denied.
In addition, with respect to drug e-commerce, it is acceptable for non-RX drugs that are not controlled drugs or drugs not allowed for retail sale. Also, the new law provides for new rights for Foreign Investment Enterprises (FIEs) in Vietnam. For example, FIEs are allowed to transfer drug materials that have been imported into Vietnam, under a tech contract to local domestic drug players. Finally, drugs can be imported into Vietnam for clinical trials without an import permit if the quantities imported meet Vietnamese requirements and the protocol has been approved by Vietnam’s MOH.
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.