Vietnam Regulatory Watch: Drug & Population Policy Updates – July 2025
Welcome to our July 2025 Vietnam Health Regulatory Update. We are committed to keeping you informed about significant regulatory changes in Vietnam’s healthcare sector. Below are the key updates:
1. Abolition of Two-Child Policy and Introduction of Draft Population Law
On June 3, 2025, Vietnam’s National Assembly approved amendments to the Population Ordinance, officially ending the longstanding two-child policy. This policy shift is in response to declining fertility rates, which fell to 1.91 children per woman in 2024, below the replacement level of 2.1. The Ministry of Health is concurrently drafting the country’s first Population Law, aiming to address demographic challenges such as aging population and regional population imbalances.
- Official Source (Vietnamese): HCMC Population Department – End of Two-Child Policy (VN)
2. New Regulations on Drug Registration
On May 16, 2025, the Ministry of Health issued Circular No. 12/2025/TT-BYT, which will come into effect on July 1, 2025. This circular introduces significant changes to drug registration processes, including:
- Abolishing the fixed list of over-the-counter (OTC) drugs, replacing it with a classification system based on specific criteria and methods.
- Simplifying requirements for the Certificate of Pharmaceutical Product (CPP) by accepting a single CPP from recognized authorities.
- Allowing submission of extension dossiers for marketing authorization at any time before expiry.
- Limiting the number of supplementation rounds during the registration process to enhance efficiency.
- Official Source (Vietnamese): DAV – Drug Administration of Vietnam (VN)
We hope this update provides valuable insights into the evolving regulatory landscape in Vietnam. Should you require further details or assistance in navigating these changes, please do not hesitate to contact us.
