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Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

In order to facilitate clinical trials, the Food and Drug Administration (FDA) has issued a notification that deals with the importation of drugs for clinical trial purposes. The notification outlines the requirements for an ethics committee to consider requests for importation of drugs into Thailand for clinical research. If approved, these drugs are then exempted from the need for drug formula registration with the FDA, until such time as the manufacturer decides to sell or distribute the drug commercially in Thailand.

In addition, a licence to import drugs into Thailand for clinical research must be obtained, which is valid for four years. However, if the clinical trials are not completed within this period, and it is necessary to import more drugs for clinical research, the licence can be renewed by filing the application form with reference to the supporting documents previously submitted to the FDA.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

Clinical trials in Thailand should follow international codes of ethics such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP). In 2000 the FDA translated the ICH/GCP into Thai for ease of reference and to act as guidelines.

Research participants must be volunteers and a high level of care has to be used. A research project has first to be approved by the Ethical Review Committee for Research in Human Subjects, which is under the purview of the Ministry of Public Health. The Ethical Review Committee has put in place guidelines and procedures for research on humans; however, these are not enforced by law and most research institutions have their own sets of guidelines and procedures.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The FDA has issued the Notification on the Requirements for Import of Drug for the Clinical Trials Research BE 2559 (2016) that imposes the reporting and disclosure requirements for the results of clinical trials. The reporting requirement consists of the submission of an annual report on the development of the clinical trial research to the FDA within October 1 and 31 of each year. Once the clinical trials are completed, a summary report must be submitted to the FDA within 60 days of the end of the clinical trials in Thailand. The FDA is empowered to inspect the clinical trials before, during and after the completion of the research project, and the researcher must afford convenience and facilitate the inspection by the FDA.

What are the informed consent obligations with respect to clinical trial subjects?

The Medical Council Regulations on Medical Ethics Preservation BE 2549 (2006) require that the medical practitioner obtain consent from the subject, and treat the subject in the same manner as a patient in a medical practice.

Informed consent is also covered by Section 9 of the National Health Act, which requires that volunteers must provide written consent before participating in any medical research. Volunteers can revoke their consent at any time. Informed consent is not limited to a one-off signature on a piece of paper, but is an ongoing process.

Insurance

What are the insurance requirements for clinical trials?

There is no specific legal obligation specifying the insurance requirements for clinical trials.

Data protection

What data protection issues should be considered when conducting clinical trials?

There is no specific law or regulation governing data protection when conducting clinical trials. However, the general principles of data protection measures should be applied to clinical trials, especially in terms of the collection and use of the trial subjects' personal data. Thus, consent must be obtained from subjects in clinical trials before or upon collection, use or disclosure of personal data. To obtain consent, the purpose of using the personal data and details of the entity that will use such data must also be stated – for example, the transfer of personal data between affiliated companies or hospitals.

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