Market Approval Process of Generic Drugs in the Cambodia

You need to know answers to the following to register your generic drug in Cambodia

  • Which is the regulatory authority in Cambodia to register your drug?
  • How can foreign manufacturers register their generic drugs in Cambodia?
  • How about Bioequivalence studies?
  • Is the foreign bioequivalence data acceptable in Cambodia?
  • What are the regulatory parameters & requirements to register your generic drug in Cambodia?
  • How about the manufacturing site accreditation, or other such requirements?
  • What are the timelines and costs involved in the generic drug registration in Cambodia?
  • 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 Cambodia.

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 Cambodia. 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.