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    5. Investigator and Investigational Product
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    5. Investigator and Investigational Product

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    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 the country?

    Not applicable.

    5.3 Does local authority allow electronic ICF administration, including electronic signatures?

    No, wet signatures are required.

    5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

    No.

    5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

    The Personal Data Protection Law No. 27 was introduced in 2022, with a transition period of 2 years. Persons controlling or processing data must comply with the regulations from October 2024. The regulations are largely based on the EU GDPR system.

    5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

    Not applicable.

    5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

    There is no specific guidance on this matter. This is subject to ethics approval.

    5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

    Study participants are allowed to receive reasonable compensation for their time. The amount is generally very low. Reasonable payment will be determined by the sponsor.

    5.9 Specific labeling requirements for clinical study product

    TEST PRODUCT INFORMATION

    Test Product: 

    1. Generic Name: 
    2. Trade Name: 
    3. Chemical Name: 
    4. Pharmacological classes (for drugs): 
    5. Dosage form and strength of Test Products:
    6. Packaging: 
    7. How to give: 
    8. Expiration date: 
    9. Batch number: 
    10. Type and quantity of Clinical Test Products to be imported (if there is an importation need): 
    11. Type and number of Clinical Test Products to be used (for local clinical trial products): 
    12. Manufacturer name and address: 
    13. Name and address of importer (if there is an import requirement): 
    14. Circulation status of the Test Product in other countries (if applicable): 
    15. In the case of products containing plants: 
    Plant name (scientific name):

    When the composition consists of several plants, describe one plant name follows scientific name and information about the compounds they contain.

    Plant parts used:

    - Source of raw material acquisition:

    - Form simplisia or extract:

    - Proof of traditional usage history (if any) and/or 

    Based on research journals:

    - Standardization carried out includes:

    Extraction method/Material preparation method

    Qualitative and quantitative determination methods of compounds 

    Active/Identity Compound

    Excerpt taken from The Head of Indonesia National Agency of Drug and Food Control Regulation No. 21 of 2015 on Procedures for Clinical Trial Approval


    5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

    Please refer to Section 2.6 of this guidebook.

    5.11 What is the turn-around time to get an import permit?

    This information is not available.

    5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

    There is no guidance on this matter.

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