2. General Questions
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2. General Questions
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2.1 Name of Regulatory Authority
The Drug and Food Supervisory Board (Badan Pengawas Obat dan Makanan or BPOM) is the Regulatory Agency governing clinical trials in Indonesia.
2.2 Name of Ethics Committee
There is no centralized ethics committee in Indonesia. Ethics committees are typically located within a research center. If the medical institution does not have its own ethics commission, the researcher can request ethical review services from the ethics commission at the nearest institution.
2.3 Clinical Trial Application Language
The core trial documents may be provided in English, but patient-facing materials must be provided in Bahasa Indonesia.
2.4 Is regulatory approval required from both regulatory authorities and/or EC?
Yes.
2.5 Can regulatory authority and EC submission be done in parallel?
Yes, the applications to the Regulatory Authority and Ethics Committee can be made in parallel, but regulatory approval cannot be granted until ethics approval has been received.
https://credevo.com/articles/2019/02/15/clinical-trials-in-indonesia/
2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin
At a minimum, the exporter or his agent must provide a pro forma invoice, commercial invoice, certificate of origin, bill of lading, packing list, and insurance certificate. Importers need to have an import license and importer identification number. If the importer intends to import without an import license, then they would need to apply for a special permit to import without API to the Indonesia Ministry of Trade. In addition to those documents, additional certificates are often required by technical agencies with an interest in the content and conformance of imported products such as food, pharmaceuticals, seeds, or chemicals.
The process of providing the documentation includes a requirement that the importer notifies the customs office prior to the arrival of goods and submits import documents electronically through the electronic data interchange (EDI) in a standardized format placed on flash drives. In addition to providing the import documentation, the Customs Office will conduct a physical inspection of imported goods. There is an import fee applicable for incoming goods which is based on the goods classification from the Indonesian Customs Tariff Book or Harmonized System Code. Since 2013, food products have been required to have Indonesian language labeling.
2.7 Biological Specimen Export Requirements
Material Transfer Agreement (MTA) is required for the export of biological materials in Indonesia to transport biological samples outside the country.
2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?
Yes, GMOs are permitted in Indonesia. They are regulated under Regulation No. 24 of 2017 on Criteria and Procedures on Drug Registration which governs biological products.
It should be noted, however, that Indonesia places significant weight on the Islamic progressive Fiqh (deep understanding), which does permit Advanced Therapy Medicinal Products (ATMPs) but only under very strict conditions. These cultural and religious considerations will be a strong focus of the ethics committee review.
Stem cell therapy for the treatment of degenerative diseases, genetic disorders, and tissue damage may use cells that come from oneself (autologous) and from other people (allogeneic), whereas the use of cells from embryonic cells, animals (xenogenic) or plants is not permitted.
2.9 Is in-country sponsor presence/representation required?
Yes, the sponsor or the CRO (ORK as known in Indonesia) must be based in Indonesia. The sponsor can be out of the country if the ORK is based in Indonesia.
2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?
Yes, the Main Investigator must be based in Indonesia – or at the clinical trial. The PI is described in Indonesia as the “Main Researcher”.
A “Main Researcher” is an individual who has the capability to lead a research team in a research center, involving supporting researchers and other personnel, and is responsible for the overall clinical trial at the research center or the location where the clinical trial is being conducted. This role is similar to that of an "investigator" as described in other jurisdictions.
The main researcher is the person responsible for the conduct of the clinical trial at the trial site. Main researchers must hold a certificate of GCP (CUKB). They will often be employed by the institution that hosts the clinical trial.
Based on BPOM Regulation 21, sponsors are responsible for carrying out the following tasks:
- Observing GCP (CUKB)
- Reporting to the sponsor and ethical commission any serious adverse event that occurs during a clinical trial in Indonesia.
2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator?
Yes. As mentioned above, a local “Main Researcher” must be identified.
2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled?
There is no specific regulation on this matter. However, sponsors need to declare when activities have been delegated to a third party.
2.13 Is there a requirement to register clinical trials on a local registry or database?
Yes, sponsors must list their trial on the Indonesian Registry Web Portal.
2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?
Medical records must be stored for at least 25 years after the patient's latest visit.
2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.
The main investigator must report any adverse drug reactions (ADR) during the trial to the sponsor as soon as possible, no later than 24 hours from the time it was first known, and to the ethical commission no later than three days. If the incident continues, subsequent reporting must be done as soon as possible until the event ends. Anticipated adverse events specified in the protocol or other documents do not require such reporting.
The sponsor must submit a report on serious ADR to the head of the Food and Drug Authority within seven days from when the event was first known for life-threatening ADR, and within 15 days for other ADR.
The sponsor must also report any unexpected serious ADR of the trial product occurring in other countries with a clinical trial center in Indonesia to the ethical commission and the head of the Food and Drug Authority.
A sponsor must suspend or discontinue a trial in progress if:
- There is a safety issue with the trial and the sponsor has consulted with clinical trial experts.
- The clinical trial was conducted without ethics committee approval.
2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim or annual progress report and final report, etc.)?
The sponsor must report on the progress of the clinical trial to the head of the BPOM:
- Once every six months;
- When the clinical trial ends; and/or
- If the clinical trial is terminated for any reason.
2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol?
Yes, breaches of GCP must be reported to BPOM as part of the six-monthly reporting process.
BPOM also has the authority to inspect the site before, during, or after the clinical trial and has the authority to terminate the project in case of any serious health risk.
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