Snapshot
The Reliance Review Pathway pathway has been developed by the Drug Administration of Vietnam (DAV) of Vietnam.
This pathway can be used where 1. Chemical drug (new drug, generic) - New drug: drugs containing new pharmaceutical substances (new chemical entities), medicinal materials, which for the first time are used for drug manufacturing in Vietnam; drugs involving a new combination of pharmaceutical substances that have been marketed or medicinal materials that have been already used in drug manufacturing in Vietnam; 2. Biologicals (Biological Reference and Biosimilars); 3. Vaccines; 4. Herbal medicines; 5. Drug materials (API, herbal semi product, excipients, capsule shell used for manufacturing of medicines). (Law 105/2016/QH13 and Decree 54/2017 and Decree 155/2018, Circular 08/2022/TT-BYT).
This pathway accelerates the regulatory review process.
It is an abridged review (a reliance pathway).
When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark EU-EMA France Germany Ireland Japan Netherlands Sweden Switzerland United Kingdom United States
Target time assessment is Vietnam introduced a reliance review pathway for NDA in 2024 via the Pharma Law revision. (Pharma Law 44/2024/QH15, Art. 56). Further guidance for this pathway is being developed at the Circular level. Category of review pathways for NDA and timeline: 1. Normal pathway – 12 months (Pharma Law 44/2024/QH15, Art. 56) 2. Reliance pathway – 9 months (Pharma Law 44/2024/QH15, Art. 56) 3. Accelerated evaluation pathway – 6 months (Circular 08/2022/TT-BYT, Art. 33). The accelerated evaluation procedure can be applied to the following drugs: Rare drugs listed by the Minister of Health; Drugs serving urgent needs for national defence and security, epidemic control or disaster relief; Domestic drugs that are manufactured by production lines that satisfy GMP, GMP-EU, or GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate; Vaccines that are approved by WHO and vaccines used for national expanded immunisation programs; Specialty drugs and drugs with special dosage forms where no more than two similar drugs (with the same active ingredients, dosage form, content or concentration) have an unexpired marketing authorisation in Vietnam when the application is submitted, including: antineoplastic drugs; next-gen antiviral drugs; next-gen antibiotics; and drugs for treatment of haemorrhagic fever, tuberculosis, or malaria. Drugs that can be domestically manufactured, including: antineoplastic drugs, vaccines, biologicals, and next-gen antiviral drugs that are manufactured in Vietnam under a processing agreement or technology transfers agreement; herbal drugs under national, ministerial or provincial research which has been accepted and drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards; and new domestic drugs that have undergone clinical trial in Vietnam. New drugs (treatment for cancer, next-gen antiviral drugs, and next-gen antibiotics) and biologicals. Brand-name drugs that are manufactured in Vietnam under a processing agreement or technology transfer agreement. 4. Abbreviated evaluation pathway – 6 months (Circular 08/2022/TT-BYT, Art. 33). The abbreviated procedure can be applied to drugs that satisfy all of the following conditions: Drugs manufactured at a local facility that is periodically evaluated by the DAV; Drugs on the list of non-prescription drugs; Drugs without modified-release dosage form; Drugs not used directly on the eyes. Applicants who have drugs satisfying these conditions can apply for an abridged procedure in the application form of the drug registration dossier..