Vietnam Updates Pharmaceutical Laws

In June 2016, the National Assembly of Vietnam updated the Law on Pharmacy, which will take effect on January 1, 2017. This version replaces the current one, which was passed in 2005 and aims to keep Vietnam’s pharmaceutical laws in line with international standards. Highlights of the Law on Pharmacy include the following:

  1. Currently, new drugs must undergo clinical trials in Vietnam. The only exception is drugs that have been legally circulated for at least five years in its country of origin. Under the new law, the clinical trial requirement will be waived for all new drugs, except vaccines. In lieu of clinical trials, drug manufacturers must have sufficient safety and efficiency clinical data, and have circulated in at least one country.
  2. Over-the-counter (OTC) drugs can be sold in businesses that do not have a certificate of eligibility for pharmaceutical business under the new Law on Pharmacy. This includes establishments that have drug counters or cabinets.
  3. Pharmaceutical companies are permitted to provide free drugs through patient assistance programs to health establishments under the new laws. Currently, Vietnam prohibits drug promotional activities targeting patients under the old laws.
  4. A new chapter in the Law on Pharmacy is dedicated to clinical pharmacology, where previously, these regulations were scattered.
  5. The new Law on Pharmacy prioritizes the purchase of domestically produced pharmaceutical products through government incentives.

Overall, these changes will have a great impact on both patients and pharmaceutical companies by providing faster access to patients, and increase domestic production.