On 22 November 2018, the Ministry of Health ("MOH") published Circular 32/2018/TT-BYT regulating the registration of drugs and drug materials ("Circular No. 32"), which will come into effect on 01 September 2019. The enactment of this Circular will render Circular No. 44/2014/TT-BYT dated 25 November 2014 regulating drug registration ("Circular No. 44") ineffective with the exception of Circular No. 44's provisions on the registration of in-vitro diagnostic biologics.
Below are some notable provisions of Circular No. 32:
1. Verification of the authenticity of legal documentation in drug registration dossiers
Circular No. 32 provides that the Drug Administration of Vietnam is to coordinate with diplomatic missions and relevant national and foreign agencies to verify the authenticity of legal documentation in drug registration dossiers. Such verification processes will be conducted at the time the relevant registration dossiers are evaluated, and within the timelines provided under the Pharmaceutical Law for the issuance, renewal and variation of the Marketing Authorization. Legal documents that require verification of authenticity are as follows:
- Certificate of Pharmaceutical Product (“CPP”) for all application dossiers for the issuance, renewal and variation of the Marketing Authorization; and
- Legal documents issued by relevant foreign authorities to Marketing Authorization Holders registering drugs in Vietnam for the first time.
Circular No. 32 also requires Marketing Authorization Holders to be responsible for coordinating with the manufacturers and foreign agencies when responding to the Drug Administration of Vietnam’s request for verification of the authenticity of legal documents pertinent to drug registration dossiers.
2. Criteria for classification as a brand name drug
For classification as a brand name drug, a specific request must be made in the drug registration dossier and the following conditions must be satisfied:
- Clinical data on the safety and efficacy of the drug is complete in accordance with this Circular; and
- Such drug is licensed for circulation by one of the Reference Regulatory Authorities or by one of the Stringent Regulatory Authorities. This requirement does not apply to new chemical entities manufactured in Vietnam
The classification as a brand name drug does not apply to biologics.
3. Requirement of two CPPs for new chemical entities and imported biologics
With regard to new chemical entities and imported biologics (excluding probiotics - digestive enzymes), the applicant must submit the CPP issued by the manufacturing country and another CPP issued by one of the Stringent Regulatory Authorities, certifying that such drugs are licensed for circulation and physically circulated in the market.