Change in Drug Registration in Vietnam

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March 21, 2019

Since the entry into effect of the 2016 Law on Pharmacy and the subsequent Decree 54/2017/ND-CP (Decree 54), pharmaceutical companies in Vietnam were eagerly awaiting a replacement for Circular No. 44/2014/TT-BYT on drug registration (Circular 44), which was based on the now-defunct Law on Pharmacy of 2005. Finally, on November 12, 2018, Circular No. 32/2018/TT-BYT (Circular 32) was issued. This circular will take effect on September 1, 2019, and will play an important role in the pharmaceutical regulatory landscape in Vietnam. Circular 32 provides clear and detailed guidelines on requirements and procedures for drug registration in accordance with the 2016 Law on Pharmacy and Decree 54.

Among the most noteworthy contents of Circular 32 is the new abbreviated evaluation procedure (within six months from the receipt date of a complete drug registration dossier) applicable to a number of over-the-counter drug registration dossiers. This procedure had previously never been available in Vietnam.

The requirements on Certificate of Pharmaceutical Product (CPP) have also been tightened under the new regulations. For example, for a new chemical entity registration dossier, rather than just requiring one CPP issued by the country of manufacture as before, at least two CPPs issued by the country of manufacture and a Stringent Regulatory Authority (SRA) are now required.

Moreover, the procedures and conditions for classification of a drug as an innovator drug are now specified for the first time in a circular on drug registration. The criteria for such classification have been completely changed compared to the previous provisional guidelines under Decision No. 2962/QD-BYT and Decision No. 1545/QD-BYT. Under Circular 32, drugs classified as innovator drugs (i) must have complete clinical dossiers; and (ii) must be licensed by either an SRA or a reference authority such as the EMA, U.S., Japan, Australia, Canada, and some EP countries. Whether the drug is protected by a patent is no longer taken into consideration.

Circular 32 does not touch on intellectual property matters with respect to registered drugs as Circular 44 did. However, Circular 32 still stipulates that the registrant must bear full responsibility for the IP issues of its registered drugs. Furthermore, the new circular and other related legal documents currently in force no longer contain provisions proscribing the withdrawal of a marketing authorization number when a drug is concluded by the authorities to be infringing IP rights. This can be considered a step backward in terms of IP protection in Vietnam.