What are regulations on documents proving a traditional drug satisfies criteria for exemption from clinical trial or certain phases of clinical trial in Vietnam?

What are regulations on documents proving a traditional drug satisfies criteria for exemption from clinical trial or certain phases of clinical trial in Vietnam?

Pursuant to Article 11 of the Circular 21/2018/TT-BYT (amended by Clause 13 Article 1 of the Circular 39/2021/TT-BYT) stipulating documents proving a traditional drug satisfies criteria for exemption from clinical trial or certain phases of clinical trial in Vietnam as follows:

1. Ancient remedy specified in point b, Clause 1 Article 7 of this Circular: Documents that prove the origin of ancient remedy according to regulations of Clause 2 Article 3 of this Circular.

2. Home remedy specified in point c, Clause 1 Article 7 or Clause 2 Article 8 of this Circular:

a) Copy that is certified or sealed by the holder of certificate of home remedy. Submission of the copy sealed by the certificate holder: it is required to have a original copy or a certified true copy for comparison of the application-receiving division;

b) Certified true copy of the result of testing of acute toxicity and semi-chronic toxicity according to regulations.

3. Traditional drugs subject to exemption from clinical trials with change in the dosage form:

a) Document on drug formulation; method of preparation for ingredients; new dosage form;

b) Manufacture process after change from the previous dosage form;

c) Document that proves the origin of the traditional drugs subject to exemption from clinical trials for the purpose of change in the dosage form

4. Traditional drugs subject to exemption from clinical trials which have change or addition to their indications according to the main effects of the drugs without change in the composition of the drug formulation, dosage or dosage form:

a) Document on drug formulation; method of preparation for ingredients; dosage form, dosage;

b) Document that proves or analyzes and justifies the addition of indications according to the main effects of the remedy;

c) Document that proves the origin of the traditional drugs subject to exemption from clinical trials.

5. Dose-adjusted remedy specified in Point dd Clause 1 Article 7 of this Decree;

a) Document that proves the origin of ancient remedy according to regulations of Clause 2 Article 3 of this Circular.

b) Document on drug formulation; method of preparation for ingredients; dosage form, method of use, dosage, indications and contraindications;

c) Document that proves or analyzes, justifies the dose-adjustment in accordance with the theory of traditional medicine

d) Certified true copy of the result of testing of acute toxicity and semi-chronic toxicity according to regulations in case the adjusted ingredient contains herbal ingredients on the list of the toxic herbal ingredients promulgated by the Minister of Health.

6. Drug that is product of scientific research:

a) Certified true copy of the record of acceptance of the scientific research topic;

b) Certified true copy of the result of testing of acute toxicity and semi-chronic toxicity according to regulations.

7. Drugs used for treatment at medical facilities specified in Clause 3 Article 8 of this Circular:

a) Document on drug formulation; method of preparation for ingredients; dosage form, method of use, dosage, indications and contraindications;

b) Certified true copy of the written acceptance of assessment of the safety and effectiveness of the Science and Technology Council of the medical facility.

8. In case of drugs that have been granted marketing authorizations, the proving document is the marketing authorization book.

9. Drug that has been granted marketing authorizations with dose-adjustment, the proving document is the registration number and the document that proves, analyzes or justifies the dose-adjustment in accordance with the theory of traditional medicine.

What are cases in which a traditional drug in Vietnam whose safety and efficacy still has to be monitored after the certificate of marketing authorization is granted?

Pursuant to Article 12 of the Circular 21/2018/TT-BYT stipulating cases in which a traditional drug in Vietnam whose safety and efficacy still has to be monitored after the certificate of marketing authorization is granted as follows:

1. The traditional drugs whose marketing authorization is applied for and safety and efficacy still has to be monitored include:

a) The traditional drugs that contain toxic herbal materials on the list of toxic herbal materials derived from minerals in the Appendix III and toxic herbal materials not starred (*) on the list of toxic herbal materials derived from plants and animals in the Appendix I and Appendix II enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Ministry of Health on the List of toxic herbal materials;

b) The traditional drugs that do not have sufficient clinical data about drug safety and the traditional drugs that are exempt from certain phases of clinical trial as prescribed in Article 8 of this Circular.

2. The traditional drugs whose marketing authorization is applied for still has to have its safety and efficacy monitored if there is not sufficient clinical data about the safety and efficacy in accordance with regulations on clinical trial.

3. The certificate of marketing authorization of the traditional drugs mentioned in Clauses 1 and 2 of this Article is valid for 03 years.

What are requirements for reports on monitoring and assessment of safety and efficiency during sale of traditional drugs in Vietnam?

Pursuant to Article 13 of the Circular 21/2018/TT-BYT stipulating requirements for reports on monitoring and assessment of safety and efficiency during sale of traditional drugs in Vietnam as follows:

Traditional drugs still has to have its safety and efficacy monitored as prescribed in Article 12 of this Article every 06 months and upon submission of the application for extension. To be specific:

1. The applicant shall send a notification of drug safety and efficacy using the Form No. 8A in the Appendix I hereof, and retain documents concerning the drug safety and efficacy.

2. The health facility that uses the drug shall send a report on the use of drug using the Form No. 8B in the Appendix I hereof, and retain documents concerning the use of drug to serve the inspection and assessment of the drug safety and efficacy.

What are requirements for clinical data about drug safety and efficacy of traditional drugs in marketing application in Vietnam?

Pursuant to Article 14 of the Circular 21/2018/TT-BYT (amended by Clause 14 Article 1 of the Circular 39/2021/TT-BYT) stipulating requirements for clinical data about drug safety and efficacy of traditional drugs in marketing application in Vietnam as follows:

1. Requirements for clinical data for the purpose of assurance about the safety and effectiveness in the marketing application of traditional drugs

a) In case of clinical studies of drugs, the data in the clinical dossiers shall be consistent with the Guidelines for preclinical and clinical research on drugs of the Ministry of Health or other organizations recognized by Vietnam, including: Research guidelines for evaluating the safety and efficacy of herbal medicines of WHO If the research is carried out before the above-mentioned regulations and guidelines for drug research and development, the research data will be considered and accepted for appraisal;

b) Traditional drugs with data cited from the following documents shall be considered as the clinical data in order to assess the safety and effectiveness of the drugs:

- Treatises relevant to the safety and effectiveness of pharmaceutical drugs that are mentioned in the pharmacopoeias of Vietnam or other countries in the world. These treaties shall contain full data on clinical trial;

- Articles about evaluation of the safety and effectiveness of drugs that have been published in journals of the SCI (Science Citation Index) and clinical data gathered from research works published in other medical literature. These articles shall contain full data on clinical trial;

- Reports on assessment of safety and effectiveness of national, ministerial or provincial science and technology projects that have been accepted.

2. The clinical studies of the drug, the data in the clinical dossiers and the technical dossiers that prove the safety and effectiveness shall be consistent with the regulations of the Ministry of Health on good clinical practice.

3. The existing data in the result of clinical trial of the drug can be used to analyze and justify the possible influence of epidemiological, pathological or living conditions in Vietnam on the safety and effectiveness of the drug.

Best regards!