MOH announced newly issued/updated administrative procedures for the pharmaceutical domain. This aligns procedures with the 2025 pharmacy framework (e.g., Decree 163/2025 and Circular 31/2025) and gives provincial DOHs and DAV a common basis to organize implementation and public guidance.

Suggested actions:

• Refresh internal SOPs and e-dossier checklists; map new forms/flows to your agents and MA holders.
• Verify which submissions must move fully online vs. hybrid; clarify routing and receipt rules with DOHs.
• Prepare a one-page explainer for commercial teams on what information must be disclosed online.

Official Source (Vietnamese): DAV news (MOH Decision 2546)

DAV added medicines with BE evidence. The consolidated lists support registration strategies where BE data can be leveraged for abridged reviews or comparator alignment. Sponsors should audit in-flight dossiers and comparator choices against the latest batches.

Suggested actions:

• Re-check BE-based routes and reference products; document any bridging rationale.
• Update country files and Module 1 summaries to reference the latest BE batches where applicable.
• For pipeline assets, build a matrix that maps molecules to available BE evidence/comparators.

Official Source (Vietnamese): DAV notice – BE List Batch 9, DAV notice – BE List Batch 10, DAV – Drug registration page

This letter to provincial DOHs clarifies implementation of administrative procedures under recent regulations – responsibilities, document hygiene, and consistent handling of applications. Multiple provincial portals have reposted the letter and attachments, indicating roll-out momentum.

Suggested actions:

• Engage local DOHs to confirm cut-over dates, submission modes, and any local checklists.
• Run an internal readiness check (roles/RACI and Q&A) for affiliates/agents handling filings.
• Create a tracker for clarifications issued by DOHs and DAV to keep teams aligned.

Official Source (Vietnamese): LuatVietnam

DAV continues to publish quality/recall notices. Maintain batch-level surveillance with distributors and ensure recall SOPs align with Circular 30/2025.

Links:

• Foreign companies with quality-violating drugs (Batch 41): https://dav.gov.vn/cong-van-so-2325qld-cl-ve-viec-cong-bo-dot-41-danh-sach-cac-cong-ty-nuoc-ngoai-co-thuoc-vi-pham-chat-luong-n4984.html
• Recall notices index: https://dav.gov.vn/cong-van-thu-hoi-thuoc-cn89.html

BPOM is Indonesia’s central authority for regulating pharmaceuticals, traditional herbal medicines, cosmetics, and food products. BPOM is responsible for evaluating, approving, and monitoring all drug products distributed in the country.

Key functions include:

• Product registration and evaluation

• Post-market surveillance and pharmacovigilance

• Good Manufacturing Practice (GMP) inspections and licensing

• Public education and counterfeit prevention

All pharmaceutical products, whether imported or locally manufactured, must be registered with BPOM before commercialization. This includes ethical drugs, Over the counter (OTC) medicines, traditional and herbal products, and biologicals.

• Step 1: Pre-Submission Preparation
  • Product classification: Determine whether the product is a new drug, generic, biologic, or traditional medicine.
  • Local representative: Foreign companies must appoint a local Indonesian agent or affiliate.
  • Document preparation: Includes administrative documents (e.g., Certificate of Pharmaceutical Product/CPP, GMP certificate), quality dossiers (e.g., Drug Master File), and clinical/non-clinical data. CPP refers to a certificate that approves the marketing of a pharmaceutical product, and GMP refers to a certificate that confirms compliance with manufacturing and quality control standards.

• Step 2: Online Submission via BPOM Portal
  • Applications are submitted through BPOM e-Registration system.: e-Registration
  • Applicants choose one of three review pathways:
    • 100-days: For orphan drugs or urgent public health needs
    • 120-days: For drugs approved in reference countries (e.g., US, EU, Japan)
    • 300-days: Standard review for new drugs or major variations registration with new indications/posology
• Step 3: Evaluation Process
  • Administrative screening: Ensures completeness and compliance.
  • Technical review: Assesses safety, efficacy, and quality.
  • GMP inspection: Required if the manufacturing site is not previously certified by BPOM.
• Step 4: Clarifications and Supplementation
  • BPOM may request additional data or clarifications. Applicants typically have 120 days to respond.
• Step 5: Marketing Authorization
  • Upon approval, BPOM issues a Nomor Izin Edar (NIE) – the official marketing authorization number, valid for 5 years and renewable upon re-evaluation.
• Step 6: Post-Market Surveillance
  • Includes pharmacovigilance, sampling, advertising monitoring, and recalls if necessary.

In 2025, BPOM launched a Regulatory Development Program (Decision No. 278/2025) to revise and streamline regulations across pharmaceuticals, supplements, and cosmetics. While the initial focus has been on food and health supplements, the roadmap signals a broader push toward:

• Digitalization of regulatory processes
• Greater transparency and efficiency
• Alignment with international standards (e.g., The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ASEAN guidelines)

Companies entering the Indonesian market should be aware of several regulatory nuances:

• Language requirements: Most documents must be submitted in Bahasa Indonesia.
• Local clinical data: Required for certain product categories, especially new chemical entities.
• Product classification: Misclassification can delay approval; early consultation with BPOM is recommended.

Strategic tip: Collaborating with experienced local partners can significantly reduce regulatory risk and accelerate market entry.

We hope this primer provides a useful starting point for navigating Indonesia’s pharmaceutical regulatory landscape. In our next issue, we will explore the structure and functions of BPOM in greater detail, including recent digital initiatives and organizational reforms.

If you are planning registration in Indonesia or considering ASEAN expansion, we are ready to support you with proven strategies tailored to BPOM’s current direction.

Effective July 1, 2025, Circular No. 30/2025/TT-BYT replaces Circular 11/2018, bringing comprehensive updates to drug quality assurance and recall protocols.

Key updates include:

• Recognition of Japanese Pharmacopoeia (JP): Companies may now use JP alongside other international pharmacopoeias (USP, EP, BP), providing enhanced flexibility in dossier preparation and product testing.
• Electronic recall notification system: Mandatory reporting of substandard products through a centralized platform, with clearer timelines and responsibilities.。
• Simplified processes for non-critical recalls, reducing disruption and improving risk-based management.

Official Source (Vietnamese): Government Portal – Circular 30/2025/TT-BYT on Drug Quality and Recall

These new provisions mark a significant shift in pharmaceutical distribution and compliance:

• Legalization of pharmaceutical e-commerce: Online platforms can now sell drugs legally if they publicly display valid business licenses and pharmacy professional certifications.
• Simplified destruction of controlled substances: Narcotics and psychotropics can now be destroyed with a 7-day advance notice, removing the need for prior MOH approval and easing operational burdens.

This opens up new commercial channels while requiring strict documentation transparency.

• Official Source (Vietnamese): Government Portal – Decree 163/2025/ND-CP on Pharmaceutical E-commerce and Controlled Substance Disposal
• Official Source (Vietnamese): Government Portal – Circular 31/2025/TT-BYT Detailed Guidelines on Implementation of the Law on Pharmacy and Decree 163/2025/ND-CP

The amended Pharmacy Law introduces major reforms aimed at attracting investment and accelerating drug market access:

• Pharma R&D and manufacturing designated as “priority sectors,” enabling access to tax incentives and land-use privileges for qualifying projects (≥ VND 3,000 billion / ~JPY 15 billion).
• Shortened registration timelines: Supplementation is now limited to two rounds, with a third only in exceptional cases.
• Simplified renewal applications if product quality has remained stable over the license term.

These changes aim to improve regulatory predictability for foreign manufacturers.

Official Source (Vietnamese): Government Portal – Law 44/2024/QH15 Amending the Law on Pharmacy