New Regulations on Drug Registration in Vietnam

October 6, 2022

New Regulations on Drug Registration in Vietnam

On September 5, 2022, Vietnam’s Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08). Circular 08 will come into effect on October 20, 2022, and replace Circular No. 32/2018/TT-BYT and its amendments, which are the current regulations on drug registration.

Below are some noteworthy contents of Circular 08:

The requirements on providing a Certificate of Pharmaceutical Product (CPP) are less stringent under the new regulations. For example, a CPP is now only required to include content as stipulated in the WHO’s CPP template. No additional contents—such as specification of finished products, APIs, herbal ingredients, and names and addresses of the API/herbal ingredient’s manufactures as under the current regulations—are required. Another new point is that, for the registration dossiers of new chemical drugs, vaccines, and imported biologicals (except probiotics), applicants are required to submit only one CPP issued by the manufacturing country if the CPP issuing authority is the EMA or any SRA (Stringent Regulatory Authority); no additional CPP/legal document is required as currently.
There will be a new option for providing legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements. In particular, in addition to a GMP certificate, manufacturing license stating the manufacturer meets GMP, CPP for API with content satisfying GMP, Certification of Suitability (CEP), or self-evaluation form, it is acceptable if the company submits a Good Agricultural and Collection Practices/GACP certificate (for herbal ingredients) or other legal documents granted by the authorities containing at least the following contents: name and address of the manufacturer, certification that the manufacturer meets GMP requirements, and name of the drug substance/excipient/capsule/semi-finished medicinal material/medicinal ingredient.
For vaccines, serums containing antibodies, and derivatives of human blood and plasma, Circular 08 introduces a more lenient policy for receiving registration dossiers. Instead of requiring a complete dossier at the time of submission, the dossier can be submitted without a certificate of analysis, quality specification, or testing method certified by the Vietnam National Institute for Control of Vaccines and Biologicals (NICVB). These papers, which can often take a long time to acquire, can be submitted later in the evaluation process, allowing applicants to secure an earlier filing date.
In addition to the procedure for declaring brand-name drugs, the procedures and conditions for classification of a drug as a reference biological are now specified for the first time.
A check from the Drug Administration of Vietnam (DAV) on the authenticity of information in legal documents in drug registration dossiers is not always required. Before granting marketing authorization (MA), the check is required in some special cases such as when the CPP shows signs of being erased or modified, or when the legal documents are related to a registrant or manufacturer having drugs registered in Vietnam for the first time. After MA has been granted, the check is required only if the DAV receives information in the form of official documents or email or through mass media reflecting that the status of approval or circulation in the host country requires verification or clarification, or that the foreign manufacturer or applicant has failed to meet operating conditions.

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Mai Thi Le

Regulatory Affairs Consultant

Vietnam

+84 24 3772 5607

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