Cambodia Drug Product Registration

MoH: Ministry of Health, Cambodia

MoH Website: https://moh.gov.kh/?lang=en

Regulatory Authority: The Ministry of Health, Cambodia and Department of Drugs and Food (DDF)  

Regulatory Authority website: https://www.ddfcambodia.com/

Local Authorised Representative: Yes

Free sale Certificate: Yes

Registration validity: 3 years

Renewal of registration: 6 months before the expiration.

Timeline for approval: 3-6 moths (take longer based on documentation and MoH workload)

Overview:

• Pharmaceutical regulation in Cambodia is overseen by the Ministry of Health (MOH) through the Cambodia Food and Drug Department.
• Under the Ministry of Health, the Department of Drugs and Foods (DDF) is the regulatory agency in charge of overseeing the quality, safety, and effectiveness of food, medicine, and cosmetics.
• The Food and Drug Department has Five bureaus

1. Registration and Cosmetics Bureau
2. Essential Drugs Bureau
3. Pharmaceutical Trade Bureau
4. Drug Regulation Bureau
5. Food Safety Bureau.

• Regulators in Cambodia accept international registration papers and data from other nations due to the country’s low capacity and inadequate laboratory facilities.
• A product can only be registered by a pharmaceutical manufacturer or a pharmacist.
• Any individual, sponsor, or company that wants to import or sell medications into Cambodia must apply for a license through the Registration and Cosmetics Bureau of the MOH Department of medications and Food Administration.
• The basic requirements for registration include

1. Samples
2. Certificate of Pharmaceutical Products (CoPP)
3. Manufacturing License
4. Good Manufacturing Practices (GMP) Certificate