INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
2. Clinical Trials 2.1 Regulation of Clinical Trials Pharmaceuticals
from the MOH by filing the prerequisite documents to the DGPMD under the MOH and paying the ser- vice fees. If the documents are deemed to be com- plete, the DGPMD will then form an evaluation team that will conduct an evaluation of the documents and deliver the result of the evaluation to the DGPMD. The DGPMD will issue an approval, refusal or deferment for the application within 20 working days from the date of receipt of the documents filed. An approval from the Health Research Ethics Committee must be obtained prior to submitting 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 prerequisite documents. The DGPMD will then give a response to the notification within 20 working days from the date of receipt of the documents filed. If the DGPMD does not provide a response within the stipulated time, the applicant may draw up a statement confirming readiness to undertake the post-marketing clinical trial. Approval from the Health Research Ethics Committee 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 generat- ed 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 informa- tion. 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 evi- dentiary purposes. The dissemination of such data is strictly confined to the directly involved parties, main- taining the integrity and confidentiality of the clinical trial process.
Under BPOM 8/2024 as amended, clinical trials of pharmaceuticals are differentiated into pre-market- ing clinical trials and post-marketing clinical trials. Conducting both types of clinical trials requires prior approval from the head of the BPOM (except for post- marketing clinical trials that are specifically undertaken in Indonesia for educational purposes). Such approval is valid for two years from the date of issuance. Medical Devices Similarly, MOH 63/2017 differentiates clinical trials of medical devices into pre-marketing clinical trials and post-marketing clinical trials. Conducting pre-market- ing clinical trials requires prior approval from the MOH. Such approval is valid for two years from the date of issuance. In contrast, a notification to the Direc- tor General of Pharmaceuticals and Medical Devices (DGPMD) under the MOH will suffice for conducting post-marketing clinical trials. 2.2 Securing Authorisation to Undertake a Clinical Trial Pharmaceuticals To secure authorisation to undertake a clinical trial of a pharmaceutical, the applicant must first submit an electronic application to obtain approval from the head of the BPOM through the official BPOM website by filing the prerequisite documents and paying the service fees. The BPOM will then evaluate the docu- ments 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 nec- essary, the BPOM will issue either an approval or a refusal of the application within 20 working days from the date of service fees payment. 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
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