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Clinical trial research need to comply with these following legal documents: Decree 98/2021/ND-CP dated November 8, 2021 on Medical Equipment Management Circular 19/2021/TT-BYT dated November 16, 2021 on Regulating Sample Documents and Reports for implementing Decree No. 98/2021/ND-CP dated November 8, 2021 Circular 29/2018/TT-BYT dated October 29, 2018 on Regulations on Clinical Drug Trials Circular 03/2012/TT-BYT dated February 2, 2012 on Guidance on Clinical Drug Trials Circular 55/2015/TT-BYT dated December 29, 2015 on Regulations for the Approval for New Techniques and Methods in Research and Clinical Trials in Medical Examination and Treatment Decision 4259/QD-BYT dated October 12, 2020 on promulgating Guidelines for research and application of cells and cell-based products in Vietnam And other informative documents from the Ministry of Health Vietnam.

The process of establishing an Local Ethics Committees needs to comply with the following legal document: Circular 04/TT-BYT dated March 5, 2020 by the Ministry of Health, on Regulating the establishment, functions, mandate and responsibility of Ethics Committees in Biomedical research.

Clinical trial research support activities in Vietnam needs to comply with the following legal document: Circular 08/2014/TT-BYT dated February 26, 2014 by the Ministry of Health on Regulating Clinical Trial Research Support Activities in Vietnam.

Clinical drug trial research files needs to comply with: Circular 29/2018/TT-BYT dated October 29, 20218 by the Ministry of Health on Regulations on Clinical Drug Trials Circular 03/2012/TT-BYT dated February 2, 2012, on Guidance in Clinical Drug Trials

According to Article 3, Chapter 1, Circular 29/2018/TT-BYT dated October 29,2018: Clinical drug trial is a scientific activity of testing drugs on volunteered patients In order to determine safety and effectiveness of drug; recognise and detect any harmful reactions to the volunteered patients due to the effects of drugs; get more understanding on drug absorption, distribution, metabolism and excretion.

According to Circular 29/2018/TT-BYT dated October 29, 2018 on Regulating Clinical Drug trials, the Clinical Drug Trial process includes 4 steps: a. Register for clinical drug trial research b. Approval of clinical drug trial research (including initial approval and approvals for any other amendments and support documents) c. Organise clinical drug trials d. Approval for clinical drug trials results

According to Section 1, Article 19, Chapter VII, Circular 29/2018/TT-BYT dated October 29, 2018, the registration dossier for clinical drug trial research includes these following items: • Documents for clinical drug trial research application • Research product information profile

According to Section 1, Article 19, Chapter VII, Circular 29/2018/TT-BYT dated October 29, 2018, IB in clinical drug trial registration must have the following contents: • General information about clinical trial drugs: name, ingredients, indications, physical and chemical properties, preparation and other related information • Pre-clinical research documents • Clinical drug trail research documents in previous stages, written in Vietnamese or in English accompanied by a clear summary in Vietnamese.

According to article 21, Chapter VII, Circular 29/2018/TT_BYT dated October 29,2018, within 5 working days from the date of receiving complete and valid documents, the Director of the Department of Science, Technology and Training, Ministry of Health Vietnam, will provide a written approval of the clinical drug research. In case of disapproval, a written response will be made clearly stating the explanation

According to Section 2, Article 19, Chapter VII. Circular 29/2018/TT-BYT dated October 29, 2018, documents submitted to request for an approval for clinical drug trial research include these following items: • An application form requesting for an approval of clinical drug research • Documents containing information about the drug for clinical trial Drug trial documents Documents about pre-clinical trial of the drug that needs to be tested Documents about the clinical trial in previous phases • Legal documents about the drugs for clinical trial • A clinical study protocol and thesis • Principal Investigator’s Academic Resume and copy of the certificate of completion of GCP Training Course which is issued by the Ministry of Health or GCP training institution • Study Information Form and Informed Consent Form • A record on scientific and ethical assessment prepared by Local Ethics Committee • Label of the drug prescribed in the Circular No.01/2018/TT-BYT dated January 18,2018 by the Ministry of Health.

According to Article 14, Chapter IV, Appendix 1, Circular 29/2018/TT-BYT dated October 29,2018: • Certificate of completion for GCP training issued by the Ministry of Health, or given by another organisation with qualified GCP training capacity; updated periodically every 3 years • Certificate of completion issued by the Ministry of Health or another organisation with qualified GCP training capacity, on completing training on “Safety Report in Clinical Drug Trials according to GCP”, updated periodically every 3 years

According to Section 3, Article 19, Chapter VII, Circular 29/2018/TT-BYT dated October 29, 2018, the document submitted to request for approval for changes in a clinical drug trial research includes these following items: • An application form requesting for approval for changes to clinical trial • An updated version of the documents • A record prepared by Local Ethics Committee on assessment of change to the clinical trial that affect the health and interests of trial subjects or the trial design, process and procedures

According to Section 4, Article 19, Chapter VII, Circular 29/2018/TT-BYT dated October 29, 2018, documents used to request for an approval of clinical drug trial results include these following items: • An application form requesting for approval for the clinical drug trial results obtained • A copy of the approved clinical trial outline • A copy of the decision on approval for the approved clinical trial outline • A record on clinical trial assessment prepared by Local Ethics Committee • A full report on clinical trial result

New methods and new techniques in clinical trials need to comply with these following legal documents: Circular 55/2015/TT-BYT dated December 29, 2015 by the Ministry of Health on Regulations on new techniques and new methods in clinical trials of medical examination and treatment Decision 4259/QD-BYT dated October 12,2020 by the Ministry of Health on promulgating Guidelines for research for the application of cells and other products from cells in Vietnam.

According to Article 6, Chapter 1, Circular 55/2015/TT-BYT dated December 29, 2015, the conditions for new techniques and new methods to be clinically tested are: • Has been carefully researched in the pre-clinical stage, with documents supporting the safety so that it can be continually tested in the next stages. • If aim to propose new techniques and new methods for clinical trials in the next stage then make sure have obtained clinical trial research results from previous stages

According to Article 11, Chapter II, Circular 55/2015/TT-BYT dated December 29,2015, documents submitted to request approval for research protocols for new techniques and new methods in clinical trials include these following items: • An application form requesting for an approval of research protocol for new methods and new techniques in clinical trials for the organisation taking on the clinical trial research process. • A signed contract of research cooperation between agencies, organisations, individuals owning the new methods and new techniques with the organisation that is taking the clinical trials process. • A signed contract between organisations and individuals with the new techniques/methods and the organisation supporting the clinical research (if there is any) • Thesis • A case report form (CRF) • Scientific background and resume of the main researcher • Document with information on the study and Informed consent form (ICF) • Report on evaluating scientifically and ethically on the research by the Ethics Committee • Documents that show professional knowledge on new techniques and new methods, such as: Pre-clinical research documents of the new techniques and methods in clinical trials: research reports on effectiveness, safety, and suggestions on how to use. Documents with information on clinical trials research in previous stages (if proposals are made for the clinical trials to go on next stages

According to Article 11, Chapter II, Circular 55/2015/TT-BYT dated December 29,2015, the application document for recognition of a new technique/method in clinical trial method includes these following items: • An application form requesting for a recognition of new technique/method in clinical trial research for the organisation that’s taking on the clinical trial research process • A photocopy of the approval certificate alongside with the research outline that has been approved • Decision to establish an internal Acceptance Council • An Acceptance Minutes from the meeting of the Internal Acceptance Council • Report results from implementing new techniques/methods in clinical trials according to regulations; and when necessary, can supplement other relevant information as well.

Clinical trials on medical equipment need to comply with the following legal documents: Decree 98/2021/ND-CP dated November 8, 2021 by the Government of Vietnam on medical equipment management Circular 19/2021/TT-BYT dated November 16, 2021 by the Ministry of Health stipulating on sample documents and reports to implementing Decree 98/2021/ND-CP dated November 8, 2021

According to Article 13, Chapter IV, Decree 98/2021/ND-CP dated November 8, 2021, requirements for medical equipment in clinical research are as stated below: • Achieve quality standards according to as stated in clinical research registration documents • The equipment’s have been tested and evaluated, to measure the technical parameters. Ensuring quality and safety • Labelling for medical equipment in clinical research must include these words: “Medical Equipment used for Clinical Research, prohibited for any other purposes”. The labelling act is carried out in accordance with regulations and laws on labelling of goods.

According to Article 15, Chapter IV, Decree 98/2021/ND-CP dated November 8, 2021, documents requesting approval for clinical research on medical equipment include these following items: • An application document requesting for an approval of clinical research on medical equipment • Information records on the medical equipment for clinical research • Legal documents of the medical equipment for clinical research • Clinical trial study protocol on the medical device and Thesis: Thesis on the clinical research of the medical device Research information collection form or Case Report Form (CRF) • A scientific curriculum vitae and a copy of certificate of completion for training on ‘Good clinical practice on medical equipment” from the main researcher of the study. The certificate must be issued by the Ministry of Health or by another organisation with qualified clinical trials training capacity. • Document provides research information and the Informed Consent Form (ICF) • Meeting minutes from the meetings by Local Ethics Committee, including appraisals on science and ethics in research • Medical equipment labels according to the provisions from Clause 3, Article 13 of this Decree; and including instructions for the use of these medical equipment in research.

According to Article 15, Chapter IV, Decree 98/2021/ND-CP dated November 8, 2021, the application for approval for the changes in clinical research of medical equipment includes these following items: • An application document requesting approval for the changes in the clinical research in medical equipment • Updated versions of corresponding documents that have been changed; specified in Clause 1 of this Article. • Meeting Minutes from Local Ethics Commitee, stating appraisals for the changes in clinical research on medical equipment that affect the health and rights of participants in medical equipment research, or influence research design, processes and procedures.

According to Article 15, Chapter IV, Decree 98/2021/ND-CP dated November 8, 2021, documents submitted to request for the approval of clinical research results of medical equipment include these following items: • A written document requesting for the approval of clinical research results on medical equipment • A copy of the research protocol that has already been approved • A photocopy of the Approval Decision on the approved research outline • Meeting minutes by Local Ethics Committee, stating appraisals in clinical research results of medical equipment • Full-text report on clinical research results of medical equipment

According to Article 15, Chapter IV, Decree 98/2021/ND-CP dated November 8, 2021; clinical research on medical equipment need to meet the following requirements: • Clinical Research records in Medical Equipment must be written in Vietnamese. In case it is not written in Vietnamese, there must be a notarised translation of that document into Vietnamese. • Documents issued by foreign management agencies must be legalised according to the provisions of law on consular legalisation, except for exempted cases according to the provisions of law.