Clinical trials must be covered by essential protocols and documents that adhere to the Good Clinical Trials Practice (Cara Uji Klinik yang Baik/CUKB), as well as relevant scientific principles, and comprise the following phases: 1) Phase I: to discover the relevant clinical and pharmacokinetic safety aspects; 2) Phase II: to estimate the dosages that are required in order to cure infected patients; and 3) Phase III: to research the efficacy and safety of Drugs in relation to infected patients

The Draft Bill on Health currently features a total of 478 articles spanning 20 chapters which, when it ultimately enters into force, will amend and repeal nine laws that already apply within the healthcare sector

Standard healthcare service tariffs are classified as those that are applicable at First-Level Healthcare Facilities (FKTP) and Advanced Referral Healthcare Facilities (FKRTL)

The obligation for drugs, biological products and medical equipment for which Certification has yet to be secured to be halal-certified is to be phased in on a gradual basis in line with the following factors: 1) The availability of materials for the products in question; and/or 2) Whether or not the relevant manufacturing processes can realistically be carried out in a halal manner. In this regard, several types of products (i.e. biological products and Class-D risk medical equipment) will be able to have halal certification secured for them up until a deadline of 17 October 2039

Healthcare facilities that organize Yandokum should issue letters of Testimony within two months of the completion of Yandokum examinations

This regulation introduces the requirements and procedures for securing approvals from the Head of BPOM for the following products: 1) Biological products (e.g. enzymes, monoclonal antibodies, hormones, vaccines, blood-based products, etc.); 2) Research drugs; and 3) Drug materials, which possess certain nutritional values and that are classified as comparison standards

Parties selling refillable cosmetics products must first secure approvals from the Head of the National Agency of Drug and Food Control (BPOM) prior to being examined

The importation of Goods may be carried out by the relevant Permit holders or may be delegated to other parties acting as drugs importation implementors (e.g. other pharmaceutical companies, wholesale pharmaceutical importers or government agencies operating within the healthcare sector)

Any entries of Materials into Indonesian territory (including into free-trade areas, ports, special economic zones and bonded consolidation locations) must also secure approvals from the Head of BPOM

The taking of a mental health examination is mandatory for certain individuals prior to their employment in certain jobs or positions. General mental health criteria apply to the following jobs or positions, among others: 1) Public officials (e.g. the president, ministers, regional heads, etc.); 2) Jobs in which an employee may have the opportunity to harm themselves or other persons and which are characterized by potential high levels of emotional pressure (e.g. police officer, soldier in the armed forces, pilot, etc.); 3) Jobs that involve vulnerable citizens (kelompok rentan) and that require certain workers to be with said vulnerable groups of people at certain times (e.g. healthcare workers and workers within the education sector who deal with persons with disabilities, the elderly and women and children); 4) Other jobs or positions that are determined by specific laws and regulations