Indonesia

DCT Feasibility Assessment Indonesia The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers...

This guidebook provides an overview of the current and proposed regulatory landscape applicable in Indonesia in relation to Decentralized Clinical Trials (“DCT”). Clinical Trials are governed in Indonesia by the Drug and Food Supervisory Board (Ba...

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. BPOM 2.2 Name of Ethics Committee There is no centraliz...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. Copies of the following documents must be provided for the Ethics Committee's review: Clinical...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. The information to be provided to the RA and EC is the same, as listed below: Clinical trial pr...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? Yes , the PI must have GCP registration. 5.2 Does local regulation require any specific documents if PI/CI is based outside th...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. There is no information on this topic. 6.2 Does local regulation require any separate consent for biological specimen collection, sto...

7.1  Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? There is no evidence for the conduct of DCTs in Indonesia to date. As a whole, the con...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   The Personal Data Protection Law No. 27 was introduced in 2022, with a transition period of 2 years. Persons control...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? There is no specific guidance on this matter. This is subject to ethics appro...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan (PIP) PIPs are not required in Indonesia. 10.3 Clinical Study (Interventional or Observational) The clinical trial requirements o...

Badan Pom (7 June 2023) Home Page ,  BPOM. Credevo (15 February 2023) Clinical Trials In Indonesia , Credevo. Pelindo (n.d.) About Us,   Pelindo. Expert Genius (2017) Search BTKI HS Code List of Indonesia 2017 ,  Ex...

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