INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
1.3 Different Categories of Pharmaceuticals and Medical Devices Pharmaceuticals Under Law 17/2023 and GR 28/2024, drugs are categorised into prescription-only drugs and non-prescription drugs. Prescription-only drugs consist of potent drugs, narcotics, and psychotropics, which must be dispensed exclusively by licensed pharmacists operating within a pharmaceutical service facili- ties. Non-prescription drugs, which are further divided into OTC drugs and limited OTC drugs, may be obtained from pharmaceutical service facilities or other facilities in accordance with laws and regulations. Law 17/2023 provides that certain potent drugs may be dispensed by a pharmacist without a prescription. Under GR 28/2024, these drugs are specified in a list issued by the MOH and reviewed based on developments in healthcare needs, science, and technology. In addition to these categories, Law 17/2023 also delineates the classification of natural medicines into traditional herbal remedies ( jamu ), standard- ised herbal medicines, phytopharmaceuticals, and other natural medicines. Medical Devices Based on the risk posed to patients by the use of medical devices, MOH 62/2017 categorises medical devices into Class A (low risk), Class B (low-to-moderate risk), Class C (moderate-to- high risk) and Class D (high risk). For in vitro diagnostic medical devices, MOH 62/2017 provides classification based on the risk posed by misinterpretation of diagnostic results to individuals and the public – ie, Class A (low risk both to individuals and the public), Class
B (moderate risk to individuals but low risk to the public), Class C (high risk to individuals but moderate risk to the public), and Class D (high risk both to individuals and the public).
2. Clinical Trials 2.1 Regulation of Clinical Trials Pharmaceuticals
Under BPOM 8/2024, clinical trials of pharma- ceuticals are differentiated into pre-marketing 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 educa- tional 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-marketing 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 Director General of Pharmaceuticals and Medical Devices (DGPMD) under the MOH will suffice for conducting post- marketing clinical trials. 2.2 Procedure for 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 prereq- uisite documents and paying the service fees. The BPOM will then evaluate the documents
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