Public ID: PID-RG5QQ9
Multi-Centre Clinical Trial Hurdles affecting UK exporters in Indonesia
Trade barrier summary
UK firms perceive the Material Transfer Agreement (MTA) Decree No. 657 of 2009 to be a barrier to conducting international clinical research in Indonesia.
The MTA prohibits the import of biological samples for laboratory tests into Indonesia, unless a sample cannot be tested in Indonesia, or if importing a sample serves the interest of quality control, i.e. updating the standard diagnostic capabilities in Indonesia.
In Multi-country clinical studies, it is essential that key laboratory tests are measured in a single centralised laboratory; to eliminate variations in the results due to the differences between laboratories.
It can take several months to obtain an MTA from the Ministry of Health. Consequently, the number of clinical studies conducted by multinational companies significantly decreased after the introduction of the MTA decree and has never recovered.
14 September 2020
1 June 2022