BPOM product registration, manufacturing licensing (CPOB), foreign ownership rules, and clinical trial frameworks for pharma companies.
This brief covers the regulatory environment for foreign pharmaceutical and life sciences companies operating in Indonesia. It addresses the BPOM product registration process — which can be the most significant market entry barrier — alongside manufacturing licensing, import procedures, and the foreign ownership framework that distinguishes between manufacturing, distribution, and retail pharmacy activities.
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| Item | Detail |
|---|---|
| Foreign ownership — pharma manufacturing | Open via PT PMA, subject to local partnership preferences |
| BPOM product registration | Required before any marketing in Indonesia — 12–36 months typical |
| CPOB (GMP) certification | Required for local manufacturing facilities |
| Import pathway (no local production) | Via SAS or registered importer/distributor |
| Halal requirement for medicine? | Generally exempt, but packaging must comply |
| Key risk area | BPOM registration timeline — plan 18–24 months minimum |
Delivered as a structured PDF or Word memo. Standard turnaround: 5 business days. One round of revisions included. Priority 2-day delivery available for +$75.
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