The readjustment of said Prohibited Raw Materials breaks down as follows: 1) Ingredients that derive from biological resources (from 165 to 156 ingredient types); 2) Ingredients that are prohibited for use in compounds in processed foods (from 35 to five ingredient types). Meanwhile, 45 Prohibited Ingredients are listed under the new regulation, including: 1) Boric acid and related substances; 2) Dulcamara; 3) Chloramphenicol; and so forth

Circular 2/2023 will now serve as a reference for the issuance of registration certificates and practice permits in the wake of the issuance of Law 17/2023

Updated the list of administrative documents that are required to be provided by cosmetics industry players that enter into production contracts in order to arrange the Product Information Documents

Seventeen hospitals have been appointed by the Minister of Health to establish CRU by no later than December 2023 in order to accelerate the organization of Clinical Research within hospitals. These hospitals include: 1) Dr. Cipto Mangunkusumo National Central General Hospital Jakarta; 2) Prof. Dr. dr. Mahar Mardjono National Brain Center Hospital Jakarta; 3) Persahabatan Central General Hospital Jakarta; 4) Dharmais Cancer Hospital Jakarta; 5) Harapan Kita Heart and Blood Vessel Hospital Jakarta

Any changes that are made to administrative, efficacy, safety, quality and/or information factors relating to drugs and their labeling that have secured distribution permits for Indonesia must be evaluated through a pre-registration process

While the Amendment has retained most of the timeframes for the submission of mandatory reports by Pharmaceutical Businesses, said Amendment now states that reports on the importation and distribution of drugs and drugs materials by PBF and PBF branches specifically must be submitted on a monthly basis by the 25th day of the following month

Human resources in clinics that are located in KEK encompass medical personnel, other healthcare workers and support staff who may be either Indonesian citizens or foreign nationals. In terms of Indonesian citizens who graduated abroad and foreign nationals who will practice in clinics that are located in KEK, mandatory evaluations will be completed so that said parties can be issued competency certification

Parties selling refillable cosmetics products must first secure approvals from the Head of BPOM prior to being examined. Said approvals can be secured through the submission of applications and by meeting the following requirements: 1) Notifications must have been secured for all distributed refillable cosmetics products; 2) Must possess refillable cosmetics product facilities; and 3) Cooperation agreements must be drafted if refillable cosmetics products will not be sold by the respective cosmetics notification holders

Producers must first secure permits from the Head of BPOM prior to initiating any PMR in line with the following process: 1) Submission of application; 2) Evaluation and field audit; and 3) Issuance of permit

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