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Drug Regulatory Process In Indonesia

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Drug Regulatory Process In Indonesia

Drug Regulatory Process In Indonesia

Ministry of Health (MoH) 

Kementerian Kesehatan Republik Indonesia

Website 

https://www.kemkes.go.id/eng/home

Regulatory Authority Name 

Badan Pengawas Obat dan Makanan (BPOM) or Indonesian Food and Drug Authority

Regulatory Authority website 

https://www.pom.go.id/

Official Language 

Indonesian/English

Regulation Name 

Government Regulation No. 74 of 1996 on Pharmaceutical Affairs

Local Authorised Representative 

Yes

Classification

New Drug, Generic Drug, Biologic, Biosimilar.

Registration Timeline

3 to 12 months

License Validity

5 Years

Registration fees

IDR 100,000 to IDR 30 million 

Commodities under the control of BPOM

Pharmaceutical • Foods • Biologicals • Traditional Medicines • Health Supplement • Cosmetics • Hazardous Substances

Documents required for product registration

  1. Administrative Documents:
    • Cover letter.
    • Certificates and administrative documents as per Annex VI.
    • Documents for determining the 100 Days pathway:
    • Justification for serious and rare diseases (Orphan Drug) and/or
    • Justification for the treatment of serious life-threatening diseases, easily transmitted diseases, or lack of safe and effective treatment options and/or
    • Supporting documents for public health programs.

Documents for determining the 120 Days pathway

  • Information on Marketing Authorization status from another country with evidence.
  • Full Assessment Report (AR) in English from the reference country authority with proposed indications and posology like the reference country.

Registration conditions with the reference country

  • Criteria for selecting a reference country (EU, US, Australia, Canada, UK, Japan).
  • Ensure identical aspects related to drug quality.
  • Declaration letter confirming the similarity of Drug Master File (DMF) submitted to the Indonesian FDA to that of the reference country.
  • Drug approval in the reference country within the last 5 years.

Documents for determining the 300 Days pathway

  • For new registration or major variations with new indications/posology not covered in the 100- and 120-Days pathways.

Drug documents related to patents (if necessary)

  • Patent-related declaration letter.
  • Results of patent searches from the Directorate General of Intellectual Property.
  • Results of patent self-assessment.
  1. Quality Documents

Quality overall summary

  • Information on animal-derived ingredients used in the manufacturing process.
  • Drug Master File (DMF) or equivalent document for Active Pharmaceutical Ingredients (APIs) not used in approved drugs in Indonesia.
  1. Non-Clinical Documents (if necessary)
  • Non-clinical overview.
  • Non-clinical tabulated summary.
  1. Clinical Documents (if necessary):
  • Clinical overview.
  • Tabulated study synopses.

Approval Process

  • The head of the NA-DFC is responsible for issuing decisions on approval/disapproval of marketing licenses.
  • In some cases, NA-DFC may request additional data to determine approval/denial of a product. In this case, the applicant must provide this requested information within 120 days.
  • If the applicant does not provide the information within the deadline, the application will be rejected.
  • However, applicants have the option to submit their documents as a new application for drug registration in Indonesia.

Non-Approval Processes

  • In instances where the National Agency of Drug and Food Control (NA-DFC) reviews an application and decides to disapprove the product, the applicant has the option to file a non-approval appeal.
  • The applicant is permitted to submit a written appeal within six months from the date of the application rejection. The appeal should be accompanied by additional product data aimed at providing stronger justification for the approval of the product.

It is important to note that applicants are limited to a maximum of two appeals in this process.

Variation Registration in Indonesia

  • Purpose: To update the registration of a drug that has already been granted market authorization but has undergone modifications.

Triggers for Variation Registration

  • Changes in license-holder
  • Trade name
  • Manufacturing site or factory name
  • Importer
  • Inactive ingredient
  • Excipient
  • Specification
  • Method of analysis
  • Packaging or labelling

Types of Variation Registration (Categories)

Category 4 (VaMa)

  • Major changes with significant impact on efficacy, safety, or quality.
  • Requires full registration process.

Category 5 (VaMi-B)

  • Minor changes that still require approval.
  • Does not fall under VaMi-A or VaMa.

Category 6 (VaMi-A)

  • Minor changes with minimal or no impact on efficacy, safety, or quality.
  • Only requires notification to BPOM (no approval needed).

Re-Registration (Category 7)

  • Separate process for renewal or extension of the marketing authorization period.

Key Points

  • The appropriate category of Variation Registration depends on the extent of change and its potential impact.
  • VaMa requires the most extensive process, while VaMi-A is the most streamlined.
  • Re-Registration is distinct from Variation Registration and focuses on extending the marketing authorization timeframe.

The Evaluation Pathway for Drug Registration in Indonesia

7 Days Pathway

  • Registration for Export-Only Drug.

10 Days Pathway

  • Renewal Registration.

40 Days Pathway

  • Minor Variation Registration.

50 Days Pathway

  • First registration of Investigational New Drugs by the Pharmaceutical Industry investing in Indonesia.

75 Days Pathway

  • First registration of the First Generic Drugs by the pharmaceutical industry investing in Indonesia.
  • Variation Registration of New Drugs and Biological Products related to quality, approved in at least 1 country with an established evaluation system.

100 Days Pathway

  • New Registration of New Drugs and Biological Products indicated for the treatment of serious diseases threatening human life (lifesaving), easily transmitted diseases, or lack of other safe and effective therapeutic options.
  • New Registration of New Drugs and Biological Products based on justification for serious and rare diseases (Orphan Drug) in Indonesia.
  • New Registration of New Drugs, Biological Products, Generic Drugs, and Branded Generic Drugs for national health programs with supporting documents or WHO prequalification.
  • First Registration of New Drugs and Biological Products by the pharmaceutical industry investing in Indonesia.
  • New Registration of New Drugs and Biological Products developed through Investigational New Drugs in Indonesia with at least 1 clinical trial conducted in Indonesia.
  • New Registration of Generic Drugs having the same specifications as Branded Generic Drugs or vice versa.
  • Major Variation Registration with new indications/posology for Drugs.

120 Days Pathway

  • New Registration of New Drugs and Major Variation Registration with new indications/posology approved in at least 1 country with an established evaluation system.

150 Days Pathway

  • New Registration of Generic Drugs and Branded Generic Drugs not covered in the 100 Days pathway.

300 Days Pathway

  • New Registration of New Drugs and Biological Products.

Major Variations Registration with new indications/posology not covered in the 50- and 75-Days pathways.

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