Generic Drug Registration Process In 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).
Advantages of Cambodia
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.
Increased demand for generic drugs followed by an easy approval process makes Cambodia a preferred destination and opportunity for generic drug manufacturers.
Regulatory in Cambodia
The Cambodia Food and Drug Department in the Ministry of Health (MOH) is the government agency responsible for pharmaceutical control in the country. The Department of Drugs and Food (DDF) 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.
The Food and Drug Department has Five bureaus
- Registration and Cosmetics Bureau
- Essential Drugs Bureau
- Pharmaceutical Trade Bureau
- Drug Regulation Bureau
- Food Safety Bureau.
Due to limited and low capacity laboratory facilities, Cambodia regulators accept foreign registration documentation and data from other countries.
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Who can apply for drug registration
- A person/sponsor/company who wishes to sell, or import drugs into Cambodia has to obtain a license registered with the MOH Department of Drugs and Food Administration through the Registration and Cosmetics Bureau.
- Only a pharmacist or a pharmaceutical company is qualified to apply for product registration.
Manufacturing facilities
- Facilities established overseas need to submit full documentation, including the plant master file, plant layout, latest GMP assessment report, and latest GMP certificate as well as other documents for consideration for certifying overseas manufacturing facilities.
- Local pharmaceutical manufacturing facilities must comply with GMPs (Pharmaceutical Inspection Co-operation Scheme (PIC/S)), and undergo training by MOH.
The basic requirements for registration include
- Samples
- Certificate of Pharmaceutical Products (CoPP)
- Manufacturing License
- Good Manufacturing Practices (GMP) Certificate
The registration process for generic drugs in Cambodia
- All the required documents along with the application are submitted to DDR.
- Before accepting the application a pre-screening review is conducted to check the completeness of the application by the authorities.
- After the pre-screening review, the complete application along with the documents are reviewed by the Subcommittee/committee.
- After review, a decision is issued by the registration and cosmetics bureau.
- The application can be revised if found any deficiency by the authorities.
Labeling Requirement in Cambodia
The law and regulation on labeling are stipulated as per the law on the Management of Quality and Safety of Products and Services. Labeling requirements are as follows
- Name of product
- Details of ingredients
- Composition User’s guidelines (direction for use)
- Manufacturing Date
- Expiry Date
- Producer name and address
- Quantity
- Batch number
Package inserts also required and it contains the product name, active ingredients, indications, instructions for use, including warnings, precautions, adverse drug reaction, and contraindication, dosage, and storage information. All labeling requirements must be in Khmer or English.
Approval timelines
The approval timeline is about 6-12 months for generic drugs. There no timeline for the review period.
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