Regulations and Process for Registering Generic Drug In Indonesia

To register your generic drug in Indonesia, you need to know the following

  • Which is the regulatory authority in Indonesia?
  • How can foreign manufacturers register their generic drugs in Indonesia?
  • How about Bioequivalence/Bioavailability studies?
  • Is the foreign bioequivalence data acceptable in Indonesia and in which conditions the bioequivalence studies are necessary?
  • What are the complete requirements to register your generic drug in Indonesia?
  • How about the manufacturing site accreditation, or other such requirements for registering the generic drug?
  • What are the timelines and costs involved in generic drug registration?
  • What is the post-approval process such as importation and license to import?

Get Details on Regulatory, Requirements, and Process for Registering Generic Drugs in Indonesia.

Credevo has prepared this report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in Indonesia. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.