On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.

On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs. Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs. The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular. In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier: Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption, Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption. Roadmap for Application From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier: Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above. Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs. From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic

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

On July 13, 2022, the Vietnamese government issued Decree No. 46/2022/ND-CP amending and supplementing some articles of Decree No. 13/2020/ND-CP providing detailed guidance on the Law on Animal Husbandry (“Decree 46”). The new decree took effect on the issuance date. Among the changes introduced by Decree 46 are a number related to animal feed. Recognition of Testing Methods of Exporting Countries Decree 46 clarifies the steps to recognize animal feed testing methods of laboratories in exporting countries. Under the amended regulations, the Department of Livestock Production (DLP) will organize an assessment team to appraise each dossier for recognition of animal feed testing methods within 30 days of receipt of a complete dossier. If the dossier lacks required information or authenticity, the DLP will organize a practical assessment team at the exporting country’s testing laboratory. If the dossier passes the assessment, within five working days from the completion of the assessment, the DLP will issue a decision on recognition of the testing method. The validity of this decision has been lengthened from three years to five years. State Inspection of Animal Feed Quality Process of State Inspection Decree 46 specifies the process to conduct state inspection of the quality of imported animal feed by unifying the regulations stipulated in the related legal documents listed in Decree 13. The process includes the submission of a state inspection dossier, timelines to receive feedback from the inspection authority, and further steps that can be taken upon receiving acceptance or refusal decisions from the authority. For traditional animal feed and complete compound animal feed, imported shipments are customs-cleared as soon as the importer completes the customs procedures. Within 15 days from the customs clearance date, the importer must submit the conformity assessment results. The importer has complete responsibility for the conformity assessment results, and