{"id":4426,"date":"2021-03-15T14:30:00","date_gmt":"2021-03-15T06:30:00","guid":{"rendered":"https:\/\/credevo.com\/articles\/?p=4426"},"modified":"2021-09-20T23:25:52","modified_gmt":"2021-09-20T15:25:52","slug":"generic-drug-registration-process-in-cambodia","status":"publish","type":"post","link":"https:\/\/credevo.com\/articles\/2021\/03\/15\/generic-drug-registration-process-in-cambodia\/","title":{"rendered":"Generic Drug Registration Process In Cambodia"},"content":{"rendered":"\n

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.<\/p>\n\n\n\n

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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.<\/p>\n\n\n\n

Top pharma suppliers to Cambodia include Sanofi<\/a> (France), GlaxoSmithKline<\/a> (UK), Zuelling pharma<\/a> (Hong Kong), Curewell<\/a> (India).<\/p>\n\n\n\n

Advantages of Cambodia<\/h2>\n\n\n\n

Registration of pharmaceutical products and the medical device is usually an inexpensive process and takes 3 to 6 months for registering, however, may sometimes take 1 year depending on the number of applications received and the workload. <\/p>\n\n\n\n

Increased demand for generic drugs followed by an easy approval process makes Cambodia a preferred destination and opportunity for generic drug manufacturers.<\/p>\n\n\n\n

Regulatory in Cambodia<\/h2>\n\n\n\n

The Cambodia Food and Drug Department<\/strong> in the <\/em>Ministry of Health (MOH)<\/strong> is the government agency responsible for pharmaceutical control in the country. The Department of Drugs and Food (DDF)<\/strong> is the regulatory agency under the Ministry of Health and is responsible for the efficacy, safety, quality of the drug, efficacy of food and cosmetics.<\/p>\n\n\n\n

The Food and Drug Department has Five bureaus <\/h4>\n\n\n\n
  1. Registration and Cosmetics Bureau <\/li>
  2. Essential Drugs Bureau <\/li>
  3. Pharmaceutical Trade Bureau<\/li>
  4. Drug Regulation Bureau <\/li>
  5. Food Safety Bureau.<\/li><\/ol>\n\n\n\n

    Due to limited and low capacity laboratory facilities, Cambodia regulators accept foreign registration documentation and data from other countries.<\/p>\n\n\n\n

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    Need support for your generic drug registration in Cambodia?<\/h3>\n\n\n\n

    Credevo offers expertise in drug product & medical device registration, clinical trial regulations, and many more services in Cambodia. Check them out now<\/a>!<\/p>\n\n\n\n

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    Who can apply for drug registration<\/h2>\n\n\n\n