The BPOM is authorized to implement technical guidance if the results of Good Clinical Testing Method (Cara Uji Klinik yang Baik/CUKB) inspections determine that corrective actions are necessary
Under the Draft Regulation, all producers in Indonesia that produce high-risk, processed food in the form of commercial sterile foods and processed foods for special nutritional needs are required to apply the Food-Safety Risk-Management Program (PMR), which should be proven through permits issued by the Head of National Agency of Drug and Food Control
All individuals that are involved in the organization of the production, storage, transportation and/or distribution of processed food products must fulfill a number of general requirements relating to the contamination of processed foods by heavy metals, which encompass types and maximum rates of heavy metal contamination within processed foods
The organization of hospital accreditation comprises the following stages: 1) Preparations; 2) Implementation of accreditation assessments; and 3) Post-accreditation
All healthcare facilities that provide occupational disease healthcare services are also required to report the recording of workers who experience or are suspected of having occupational diseases to the relevant insurance providers and said reporting must be completed through information systems that are operational at healthcare facilities and that are integrated into the information systems of insurance providers
Through the rendering of Decision No. 31 P/HUM/2022, the MA has now affirmed that Article 2 of Regulation 99/2020 is in contradiction with a number of higher laws and regulations, specifically various provisions set out under Article 4 of Law No. 33 of 2014 on Halal Product Guarantees, as long as it is not interpreted to mean the following: "The government (Minister of Health, Committee for the Handling of COVID-19 and National Economic Recovery and the Head of the Food and Drug Supervisory Agency) is obliged to provide protection and guarantees regarding the halal status of the types of COVID-19 vaccines that are stipulated in relation to the implementation of COVID-19 vaccinations within the territory of Indonesia"
In order to advertise any traditional medicines, quasi-medicines and health supplements, advertising approvals must first be secured from the Head of the BPOM. Advertising approvals fall into two categories, specifically: 1) Major advertising; and 2) Minor advertising
Indications of Omicron infections are reliant on S Gene Target Failure (SGTF) or Single Nucleotide Polymorphism (SNP). Accordingly, in order to confirm any indications of Omicron infection, testing should be carried out based upon the capacities of healthcare facilities in relation to the abovementioned detection measures
Existing operational licenses and the relevant operational commitment statements will remain valid until 18 August 2022, while existing accreditation certificates and statements outlining commitments to maintaining and improving the quality of the relevant healthcare-service facilities will remain valid until 18 February 2023
Clinical testing will be carried out at clinical trial centers that have secured letters of recognition from the BPOM and that employ a main researcher and at least one co-researcher who have secured certificates of good clinical testing practice