INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
and may request for a correction to be made and/or additional data to be provided. If the BPOM deems no correction and/or additional data is necessary, the BPOM will issue either an approval or a refusal of the application within 20 working days from the date of service fees pay- ment. Approval from the head of the BPOM to undertake a clinical trial will only be given after an approval from the Health Research Ethics Committee is obtained. Medical Devices Pre-marketing clinical trials To secure authorisation to undertake a pre- marketing clinical trial of a medical device, the applicant must first submit a written application to attain approval from the MOH by filing the pre- requisite documents to the DGPMD under the MOH and paying the service fees. If the docu- ments are deemed to be complete, the DGPMD will then form an evaluation team that will con- duct an evaluation of the documents and deliver the result of the evaluation to the DGPMD. The DGPMD will issue an approval, refusal or defer- ment for the application within 20 working days from the date of the receipt of the documents filed. An approval from the Health Research Eth- ics Committee must be obtained prior to submit- ting a pre-marketing clinical trials application. Post-marketing clinical trials To secure authorisation to undertake a post- marketing clinical trial of a medical device, the applicant must first submit a written notification to the DGPMD under the MOH by filing the pre- requisite documents. The DGPMD will then give a response to the notification within 20 working days from the date of the receipt of the docu- ments filed. If the DGPMD does not provide a response within the stipulated time, the appli- cant may draw up a statement confirming readi- ness to undertake the post-marketing clinical.
Approval from the Health Research Ethics Com- mittee must be obtained prior to submitting a post-marketing clinical trials notification. 2.3 Public Availability of the Conduct of a Clinical Trial The conduct and results of a clinical trial both for medicines and medical devices will not be listed in any publicly accessible database. The data generated by clinical trial institutions (eg, hospitals, research centres, and universities) is safeguarded and retained exclusively within these entities, ensuring that no external party is authorised to access such information. In practice, the release of clinical trial data requires the explicit consent of all parties involved. For instance, in the event of a serious adverse incident, the data may be disclosed solely by mutual agreement for evidentiary pur- poses. The dissemination of such data is strictly confined to the directly involved parties, main- taining the integrity and confidentiality of the clinical trial process. 2.4 Restriction on Using Online Tools to Support Clinical Trials There are no restrictions for using online tools to support clinical trials (eg, for recruiting or moni- toring purposes). 2.5 Use of Data Resulting From Clinical Trials If the data generated from clinical trials can be used to identify an individual, it is deemed as personal data under Law No 27 of 2022 on Per- sonal Data Protection ( “Law 27/2022” ). Under Law 27/2022, any transfer of personal data to an external entity is strictly prohibited unless con- sent has been obtained from the data subject.
154 CHAMBERS.COM
Powered by FlippingBook