How long does pharmaceutical drugs registration take in Indonesia?
Median and typical-range figures computed from real BPOM approval data.
Data sourced from BPOM, updated daily.
Pharmaceutical drugs require a marketing authorization from BPOM, the Nomor Izin Edar (NIE), valid for five years. The prefix encodes the drug class: the letters mark whether a product is over-the-counter (bebas), limited over-the-counter (terbatas) or prescription-only (keras), and whether it is branded or generic.
Drug evaluation is more involved than the notification route used for cosmetics, reflecting the clinical dossier BPOM reviews. As with every BPOM category, a foreign company registers through a local license holder.
How registration works
- Appoint a local license holderThe marketing authorization is held by an Indonesian entity.
- Compile the pharmaceutical dossierComposition, manufacturing and quality data, GMP certification, and a Free Sale Certificate.
- Submit to BPOM for evaluationRespond to BPOM queries during the technical and clinical review.
- Receive the NIEThe marketing authorization is valid for five years before renewal.
What you need
- A local license holder.
- A full pharmaceutical dossier with quality, manufacturing and where relevant clinical data.
- GMP certification and a Free Sale Certificate from the country of origin.
Reading a BPOM number
The prefix on a registration number tells you the product type and, for many categories, whether it was made in Indonesia or imported.
| Prefix | Product type | What it means |
|---|---|---|
| NA, NB, NC, ND, NE | Cosmetic | Notification. The second letter is the region of manufacture: A Asia (incl. Indonesia), B Australia, C Europe, D Africa, E the Americas. |
| NK | Cosmetic | Older cosmetic registration scheme. |
| MD | Processed food | Produced in Indonesia (dalam negeri). |
| ML | Processed food | Imported (luar negeri). |
| SD, SI | Health supplement | SD produced domestically, SI imported. |
| TR, TI | Traditional medicine | Jamu and herbal products. TR domestic, TI imported. |
| DK, DBL, DTL, GKL | Pharmaceutical drug | Marketing authorization (izin edar / NIE). The class letters mark over-the-counter, limited, or prescription status. |
| AKD, AKL | Medical device | Registered with the Ministry of Health, not BPOM. AKD domestic, AKL imported. |
| PKD, PKL | Household (PKRT) | Household and personal-care products, regulated by the Ministry of Health. PKD domestic, PKL imported. |
Frequently asked questions
The NIE (Nomor Izin Edar) is the BPOM marketing authorization a drug needs before it can be distributed in Indonesia. It is valid for five years.
The class letters mark over-the-counter, limited over-the-counter or prescription status, and whether the product is branded or generic.
Drug evaluation is longer than other categories. The timeline tool shows current figures drawn from real approval data.
Data sourced from BPOM, updated daily. BPOM registration with Emerhub.