The enactment of this regulation represents a significant step forward in refining Indonesia’s pharmaceutical legal framework. The previous regulation, namely, BPOM Regulation No. 16 of 2015, was often considered too general and resulted in differing interpretations among the pharmaceutical industry and academia. Through this new regulation, BPOM affirms its commitment to establish a more structured, transparent, and internationally aligned drug evaluation system.
Regulatory Amendments Background
Advancements in health sciences and technology have spurred the emergence of various new drug candidates. However, without a clear and stringent evaluation mechanism, the potential risks to patient safety, product quality, and reliability of research data increase significantly.
As the regulatory authority, BPOM carries a strategic mandate to ensure every drug circulating in the market complies with the standards of efficacy, safety and quality. Accordingly, the refinement of procedures for NDD approval is not merely administrative, but an integral part of safeguarding the integrity of the national health system and protecting the public.
Expansion of Eligible Applicants
One of the most notable changes introduced under BPOM Regulation No. 24 of 2025 is the expansion of entities eligible to apply for NDD approval. Whereas on the previous regulation the entities are limited to research institutions and pharmaceutical industries, now the scope has been expanded to include:
- Pharmaceutical industries;
- Hospitals;
- Institutions engaged in drug manufacturing;
- Institutions engaged in radiopharmaceutical preparation;
- Facilities/laboratories for cell and/or stem cell processing;
- Contract research organizations; and
- Research institutions.
With broader scope, the regulation not only stimulates innovation within the industry but also creates opportunities for wider participation from healthcare and research institutions in drug development.
More Detailed Evaluation Procedures
The new regulation introduces several technical provisions that are more comprehensive than the previous framework. Key highlights include:
1. Evaluation Timeline
The evaluation of NDD applications is now set at a maximum of 100 (one hundred) working days from the date of payment of Non-Tax State Revenue (PNBP) by the applicant. This mechanism adopts a “clock-on” and “clock-off” system to ensure greater transparency in time calculation.
The difference from the previous regulation lies in the provision of 3 (three) chances for the applicant to clarify or supplement their data, provided that clear justification is given.
2. Validity Period and Extension
An NDD Statement Letter issued by the Head of BPOM is now valid for 5 (five) years from the date of issuance. This Statement Letter may be extended by submitting an application no later than 30 (thirty) days before its expiry date. Interestingly, no PNBP fees are charged for extensions, thereby easing the administrative burden for applicants.
3. Annual Reporting Obligations
Each applicant who obtained approval is required to submit annual progress reports on the development of the NDD at the very least once a year. The said report requires to include, among others:
- Clinical Trial information;
- summaries of prior Clinical and Non-Clinical Trial data;
- plans for subsequent Clinical Trial phases;
- summaries of any amendments to the investigator’s brochure or clinical trial protocol; and
- circulation status in other countries, including information on any withdrawal or suspension from the market.
This reporting obligation ensures BPOM’s continued oversight of research and provides ongoing protection to the public through stricter safety and quality standards.
Regulatory Impact on the Pharmaceutical Industry
The implementation of BPOM Regulation No. 24 of 2025 is expected to have a dual impact. On one hand, stricter standards require pharmaceutical companies and research institutions to operate with greater discipline, transparency, and accountability. On the other hand, clearer procedures provide legal and investment certainty, fostering a more robust research environment.
For the pharmaceutical industry, this regulation also represents an opportunity. With evaluation standards increasingly aligned with global practices, Indonesia is positioned to play a more prominent role in international drug research, development, and production.
Digitalization of Processes and Service Efficiency
To support the implementation of the new regulation, BPOM has launched a digital platform to facilitate application submission, monitoring, and communication between applicants and the authority. Through this system, application status can be tracked in real-time, thereby expediting decision making and minimizing bureaucratic obstacles. This digitalization simultaneously strengthens transparency, reduces the potential of administrative overlap, and increases the accountability of public services.
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