Law Number 17 of 2023 concerning Health Article 340 paragraph (2) states that the transfer of material in the form of clinical specimens and biological materials, information content, and/or data may only be carried out if:
a. the means of achieving the intent and purpose of the audit cannot be carried out in Indonesia;
b. the examination can be carried out in Indonesia but to achieve the main objective of the research, it is necessary to carry out the examination outside the territory of Indonesia; and/or
c. for the purpose of quality control in order to update the accuracy of diagnostic and therapeutic standard capabilities.
Government Regulation Number 28 of 2024 Article 1028 states that the transfer and use of materials in the form of clinical specimens and biological materials, information content, and/or data to and from the territory of Indonesia and between regions in Indonesia may only be carried out after obtaining approval from the Central Government through the approval of the Minister of Health.
The transfer and use of materials in the form of clinical specimens and biological materials, information content, and/or data is a physical and/or digital transfer process, and must be accompanied by a material transfer agreement or what is currently known as MTA (Material Transfer Agreement). Technical provisions for the approval service for the transfer of material in the form of clinical specimens and biological materials, information content and/or data using MTA (Material Transfer Agreement) regulated in Regulation of the Minister of Health.
MTA Application Form :
Information about the requirements and application procedures can be seen at the link the following.
MTA format according to Minister of Health Regulation No. 85 of 2020:
1. Format of Cooperation Agreement Guidelines (PKS)
2. MTA Full Type
3. MTA Type Between
4. MTA Simple Type
5. Clinical Trial Agreement Guidelines Format
6. Standard Format of Data Sharing Agreement
