INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
2.4 Use of Online Tools to Support Clinical Trials There are no restrictions for using online tools to sup- port clinical trials (eg, for recruiting or monitoring pur- poses). 2.5 Use of Data From Clinical Trials If the data generated from clinical trials can be used to identify an individual, it is deemed personal data under Law No 27 of 2022 on Personal Data Protection (“Law 27/2022”). Under Law 27/2022, any transfer of personal data to an external entity is strictly prohib- ited unless consent has been obtained from the data subject. Additionally, Article 1 (9) of BPOM 8/2024 as amended and Article 1 (6) of MOH 63/2017 affirm that the confi- dentiality of information relating to individuals partici- pating in clinical trials of pharmaceuticals and medical devices is part of the Good Clinical Practice standard ( Cara Uji Klinis Yang Baik ), which must be complied Under Law 27/2022, the creation of a database con- taining personal information requires the explicit con- sent of the data subject. Further, GR 28/2024 provides that health information system providers must store health data and health information in a database that is located in a safe place and is not damaged or easily lost by using electronic and/or non-electronic storage media. These databas- es may utilise servers, cloud computing systems, or other storage media in accordance with technologi- cal development. Such database must be hosted in a data centre located within the territory of Indonesia. Although storage services and facilities owned by a third party may be used, such arrangements must adhere to the following conditions: • the storage must be implemented within Indone- sia’s jurisdiction; • a formal co-operation agreement must be in place, which contains at least provisions on confidential- ity, service level, and service level target; with in conducting clinical trials. 2.6 Personal or Sensitive Data
• the health data and information are owned and fully controlled by the health information system pro- vider; and • the data processor must fulfil all data processor obligations under Indonesian law.
3. Marketing Authorisations 3.1 Product Classification
Under Law 17/2023, medical devices are defined as instruments, apparatus, machines, equipment, implants, in vitro reagents and calibrators, software, and materials or similar that are used on humans for medical purposes and do not achieve their primary action through pharmacological, immunological, or metabolic processes. In contrast, drugs are defined as substances or mix- tures thereof (including biological products) that are intended for human consumption to influence or examine physiological systems or pathological condi- tions for the purposes of diagnosis, prevention, treat- ment, recovery, health improvement, and contracep- tion. 3.2 Marketing Authorisation for Biologic Medicinal Products Biological products (eg, vaccines) fall within the defini- tion of drugs and thus fall under the same regulations. 3.3 Period of Validity of Marketing Marketing authorisation for pharmaceuticals is issued with a maximum validity period of five years. Renewal of marketing authorisation for a pharmaceutical must be submitted no earlier than 12 months and no later than two months before the current authorisation expires. Marketing authorisations for pharmaceuticals can be suspended and/or revoked in the event of: • violation of the obligation to make and send a pro- duction report or import report of imported drugs to the BPOM in accordance with laws and regula- tions; • revocation of the industrial licence of the marketing authorisation owner; or Authorisations Pharmaceuticals
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