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.
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