Market Approval Process of Generic Drugs in the Cambodia

Market Approval Process of Generic Drugs in the Cambodia

The demand for healthcare products and services has been growing in ASEAN countries. Governments start facing the same problem as in more developed countries and struggle to finance the growing healthcare expenses. There is a steep increase in chronic diseases along with infectious diseases. This is creating an opportunity for the generic drug manufacturers to enter these countries for registering and market their drugs in these demanded countries to meet the medical needs.

With a population of over 16 million, pharmaceutical spending has grown from $265 million in 2016 to $295 million in 2017 and is projected to $437 million by 2021 in Cambodia. About 55% of the market has imported drugs signifying the demand for foreign drugs. Currently, for pharmaceuticals, France is one of the top supplier's followed by India.

Top pharma suppliers to Cambodia include Sanofi (France), GlaxoSmithKline (UK), Zuelling pharma (Hong Kong), Curewell (India).

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

  • 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.