Regulatory affairs through the lifecycle
From development conversations to post-market filings, we keep BPOM expectations visible and actionable.
Overview of Pharmaceutical Product Registration in Indonesia
>10 NDA submissions in Indonesia, including NCE, biologics, generics, cosmetics, health supplements, traditional medicine.
Handled Marketing Authorization Transfers, regulatory support for transfer inventory and grace period between Product Owner and Distributor.
Regional markets we support
Indonesia: sustain the product, not only the first approval
Our Indonesian work centers on keeping products alive after the first BPOM decision—variations, PSUR and ICSR handling, defect response, dossier gap analysis, and product-owner regulatory accountability across the lifecycle.
Full pharmaceutical MAH infrastructure is a separate build; meanwhile we strengthen the layers that protect marketed products every week: regulatory affairs navigation, pharmacovigilance setup, and GMP/GDP compliance frameworks that survive both routine and for-cause scrutiny.
When sponsors ask what “local support” means in Jakarta, the answer is concrete: dossier hygiene, safety signal handling, and a compliance spine that keeps import and distribution decisions defensible.
Sustainability services we run now
Pharmacovigilance that can be audited
Local PV systems, adverse-event flow, and inspection readiness with your quality partners.
Compliance framework
GMP, GDP, and quality standards woven into how import and distribution decisions are made.
Who governs the path
BPOM (NADFC) guards safety, efficacy, and quality for Indonesian pharmaceutical products. Registration is a staged conversation with that Agency—not a single upload.
Submission of Application to BPOM
Inspection (if necessary)
Key points
Dossier Preparation: Prepare a complete registration dossier that
Dossier Preparation: Prepare a complete registration dossier that includes: Product information (e.g., composition, strength, dosage form). Clinical trial data (if applicable) to demonstrate safety and efficacy. Manufacturing site details, GMP compliance certificates, and quality control measures.
Submission: Submit the registration application through BPOM's online
Submission: Submit the registration application through BPOM's online system, e-Registration. This includes submitting all necessary documentation and paying the required fees.
Post Approval Changes
Post-Marketing Surveillance and Reporting (Pharmacovigilance, Renewal of Registration) The pharmaceutical product registration process in Indonesia is thorough and involves compliance with regulatory standards to ensure the safety, quality, and efficacy of drugs. Companies planning to enter the Indonesian market must carefully follow BPOM’s procedures, submit comprehensive documentation, and be prepared for potential inspections.
(such as transdermal patches, implants, and beads)
Key points
WHO, ICH, EMA, US-FDA
Regulation of NADFC / BPOM
Checklist(s) issued by NADFC / BPOM
Manual Book / User Manual of registration online system
Chemical Drug / New Chemical Entity (NCE)
Health and Food Supplements
Other preparations containing drugs with special technology, such as transdermal patches, implants, and beads
The Indonesian applicant is the local pharmaceutical industry
BPOM speaks with a licensed Indonesian Pharmaceutical Industry as applicant—the party responsible for regulatory completeness and day-to-day Agency interaction. Foreign manufacturers appoint that local industry partner; we help make the appointment and the dossier story coherent from CPP through labelling.
Expect scrutiny on composition, manufacturing narrative, stability, clinical justification where required, and Bahasa Indonesia labels that match BPOM’s published expectations—not a translated afterthought.
Core dossier pillars
CPP or Free Sale Certificate from the country of origin
GMP evidence—with possible BPOM inspection of foreign sites
Composition, process, stability, and clinical packages as applicable
Bahasa Indonesia labelling meeting BPOM rules
Safety/efficacy justification and any prior foreign marketing authorizations
How BPOM evaluates
01
Quality
Manufacturing and stability under review.
02
Safety & efficacy
Clinical and scientific evidence weighed for Indonesian use.
03
Label check
Language, warnings, and dosage instructions verified.
04
GMP clearance
Import products may face facility inspection.
05
NRA number
Marketing authorization issued—typically valid about five years—and listed in BPOM’s database.
After the NRA number: stay marketable
Approval is the starting gun. Pharmacovigilance, five-year renewals, labelling in Bahasa Indonesia, and e-Registration discipline decide whether the product stays on shelves. Fees follow product type and complexity—budget them as part of the critical path, not a surprise invoice.
Biologics and biosimilars often carry heavier clinical expectations; traditional medicines follow a distinct but still evidence-based path; imports still clear customs and documentation gates before they reach patients.
Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership.
Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations.
We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework.
Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters.
Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function.
PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan.
Post-approval realities
Always on
- Adverse-event reporting to BPOM
- PSUR and renewal cycles
- Manufacturing, labelling, and distribution compliance
Special paths
- Biologics/biosimilars: deeper clinical expectations
- Traditional medicines: distinct but still evidence-based routes
- Imports: customs and documentation gates
Where we plug in
Pre-market strategy and gap analysis
GMP advisory and dossier handling
Local entity support and lifecycle PV
Import licensing, PRH changes, and ad-hoc consultation
Engagement notes
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function
- PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
Engagement notes
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function
- PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
Engagement notes
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function
- PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function
- PECAN.Solutions scopes each workstream with milestones, document owners, and authority touchpoints so registration, license holding, and commercial access stay on one plan
Engagement notes
- Our team documents assumptions, authority expectations, and decision points so sponsors can approve the plan with clear risk ownership
- Local pharmacists and regulatory specialists stay accountable through query cycles, inspection readiness, and post-approval obligations
- We align labeling, Module 1 localization, and partner communications so commercial launch can follow approval without rework
- Where pathways differ by product class, we sequence filings to protect the critical path and avoid avoidable deficiency letters
- Engagements can scale from a single dossier workstream to a multi-country virtual regulatory function