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Indonesia - Regulations for Drug (Pharmaceutical) Registration

Updated: Jun 20, 2023

  • Indonesia's pharmaceutical market is the largest market in the Southeast Asia region.

  • The Indonesia pharmaceutical market size was $8.6 billion in 2021

  • Indonesia is one of the fastest-growing countries in the Association of Southeast Asian Nations (ASEAN) region, making it one of the most alluring emerging markets for pharmaceutical companies seeking to expand in the Asia-Pacific region. (Source: Global Data)


Legislation and Authorities Governing Regulations for Drug (Pharmaceutical) Registration in Indonesia

The National Agency of Drug and Food Control (BADAN POM) supervises drug and food control in Indonesia under the Health Law No. 36 of 2009 and is responsible for Governing Regulations for Drug (Pharmaceutical) Registration in Indonesia.


Other regulations that govern the drugs in Indonesia include,

  • Narcotics Law No. 35 of 2009.

  • Psychotropic Law No. 5 of 1997.

  • Drugs Ordinance (Sterkwerkende Geneesmiddelen Ordonnantie, Staatsblad 1949:419).

  • Presidential Regulation No. 80 of 2017 concerning the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan).

  • Government Regulation No. 72 of 1998 concerning Custody of Pharmaceuticals and Medical Devices.

Products Regulated by NADFC

  • Pharmaceutical

  • Foods

  • Biologicals

    • Biotech Products

      • Recombinant Protein

      • Monoclonal Antibody

    • Vaccines

      • Conventional Vaccines

      • Biotech (Recombinant)

    • Cell/Gene Therapy

    • Extraction / Functional Products

  • Traditional Medicines

  • Health Supplement

  • Cosmetics

  • Hazardous Substances


Drug Registration Process in Indonesia


pharmaceutical-drug-regulations-indonesia-regulatory-affairs-consultant-service
Pharmaceutical Drug Regulations in Indonesia


Requirements for Imported Drugs in Indonesia


Who Can Apply?

Domestic Manufacturers in Indonesia can apply for Drug Import Application based on authorization from Foreign Manufacturers.

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Manufacturer Criteria:
  • Domestic Manufacturer must have a valid GMP license with last date of inspection within last 2 years.

  • Site Master File (SMF) in case if the manufacturer does not have same dosage form authorized to be marketed in Indonesia OR if there is a change in production facility for marketed same dosage form

    • Site Inspection can be conducted if SMF requires evidence of GMP compliance

    • Online Submission and Licensing System in Indonesia

    • Online Single Submission Service (OSS)


Artixio’s regional presence in Indonesia and experience with pharmaceutical products compliance in the country has helped our clients access the market to register and introduce their pharmaceutical products in Indonesia. We can support through entire product lifecycle using regulatory advisory and operational services for new molecules, generic drugs, biologics and biosimilars. Please read about our services in Indonesia here


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