Drug Registration and Marketing Authorization Regulations Revised

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) is currently drafting a Draft Regulation on the Criteria and Procedures for Drug Registration (“RPerBPOM”). This regulation is required to align the drug registration procedures with the latest legal framework, including Regulation of the Government No. 15 of 2026 on Types and Tariffs of Non-Tax Government Revenue (“PNBP”) Applicable to the Indonesian Food and Drug Authority (“PP 15/2026”).

“The draft is currently awaiting harmonization with the Ministry of Law and Human Rights, so our position at BPOM is still to wait,” said Elin, Head of the Working Team for the Registration of Natural Medicine Products, Quasi Drugs, and Health Supplements.

Compared to the currently applicable framework, the latest RPerBPOM introduces several new provisions. One of these is the addition of an evaluation timeline for packaging design in order to accommodate the needs of business actors in refining their labeling designs. Under the draft regulation, such refinements may be carried out a maximum of two times within a period of 10 business days.

In addition, the new regulation also introduces provisions on the validity period of marketing authorizations under certain conditions and re-registration procedures. These provisions include the determination of the validity period of marketing authorizations in specific circumstances, as well as the stipulation that marketing authorizations granted through re-registration shall become effective upon the expiry of the previous marketing authorization period.