BPOM Revises New Drug Regulation to Accelerate Clinical Trial

The government is currently discussing revisions to Regulation of the National Agency of Drug and Food Control (“ BPOM ”) No. 16 of 2015 (“ PerBPOM 16/2015 ”) on Procedures and Evaluation of New Drug Development (Obat Pengembangan Baru– “ OPB ”), as the implementing regulation of Article 383 paragraph (4) of Regulation of the Government No. 28 of 2024 (“ PP 28/2024 ”), which regulates product approval and development. A Mid-Level Expert in Laws and Regulations Drafting at BPOM, Henny Mildawaty, stated that this regulation covers new drugs prior to clinical trials in Indonesia.

“It has been harmonized with the Ministry of Law (Kemenkum). The substance under discussion concerns the procedural mechanism for the evaluation of new drug development,” said Henny to Hukumonline.

Draft BPOM Regulation on Procedures for the Evaluation of New Drug Development (“ Draft PerBPOM ”) also regulates the extension of the validity period of the OPB Certificate from two years to five years. This amendment is considered more in line with the reality of the drug development process, which requires a lengthy period, while also encouraging progress in Health science.

“It is targeted to be finalized and issued shortly,” she added.