BPOM Prepares Regulation on New Drug Approval Pathway

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan – “BPOM”) is preparing a regulation on conditional approval as a new pathway for drug authorization. Head of BPOM, Taruna Ikrar, stated that the new pathway is intended to complement the existing authorization mechanisms by accelerating access to innovative medicines without compromising safety, quality, and efficacy standards.

“The conditional approval scheme is intended for innovative medicines, particularly advanced therapy medicinal products (“ATMPs”),” he said.

Taruna explained that the expedited drug authorization process under the conditional approval pathway will utilize a reliance mechanism, whereby BPOM will rely on product assessments conducted by regulatory authorities in other countries that meet high regulatory standards, such as WHO Listed Authorities.

“This means that we do not need to conduct redundant or repeat testing because we already rely on those assessments, thereby accelerating the process,” he said.

Despite the use of the reliance mechanism, Taruna emphasized that the conditional approval pathway will not compromise the safety, efficacy, and quality standards applicable to approved products. According to him, in implementing this mechanism, BPOM will continue to apply a risk-based supervision framework to ensure the quality of approved products.