Preclinical and Clinical Trial Requirements
Preclinical and clinical trial requirements in Indonesia – an overview. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
No, clinical trials do not have to be conducted locally for applying for MAs. The applicants must provide clinical trials results to prove the efficacy and safety of the drugs, although it is not necessarily performed in Indonesia.
2. How are clinical trials funded?
Clinical trials are funded by sponsors. Sponsors can be any individuals, companies, institutions or organizations.
A sponsor, including foreign sponsor, may engage research organizations to conduct the clinical trial.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
A clinical trial protocol must elaborate:
- the organization of a clinical trial,
- the background,
- method, and
- statistical consideration,
in relation to the trial.
The protocols are a supporting document that must be submitted together with the application to obtain clinical trial approval. Clinical trial approval for drugs is issued by Head of BPOM drug, whilst trial for medical devices must be approved by MOH through the Directorate General of Pharmaceutical and Health Devices (Direktorat Jenderal Kefarmasian dan Alat Kesehatan – “DGPHD”)
4. What are the requirements for consent by participants in clinical trials?
The subjects or participants of clinical trials must provide a written consent called Informed Consent (Persetujuan Setelah Penjelasan).
The Informed Consent must be obtained from the participant voluntarily after the participant has been fully informed on the whole aspects of the clinical trial which he/she will be participating into, including side effects and benefits of the trial. The Informed Consent must also contain the procedure in the event of any undesirable event or serious undesirable event.
5. May participants in clinical trials be compensated?
The participants in clinical trials may be compensated, both in form of financial compensation or form of healthcare treatment. However, the compensation amount must not be too large or too insignificant as it may affect the participants.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
There is no explicit regulation that provides indemnification to participants against any harm that arises as a result of participation in the trial.
However, the Informed Consent that is approved by the participants must provide a clear understanding on all clinical trial’s aspects before its commencement. This Informed Consent also contains information on the compensation and other benefits which will be obtained by the subject of clinical trial. Therefore, the subject will fully understand his/her rights arisen from participating in the clinical trial and may claim such rights to the clinical trial’s initiator.