Safeguarding Public Health Through Comprehensive Regulation

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

Regulatory Guidelines:

• Accepts ACTD format.
• Form of submission: Hard copy and CD-ROM
• Language for submission: English or Khmer

Cambodia Drug Registration Process

• Companies can use the Cambodia Pharmaceutical Online Registration System (CamPORS), a MOH registration platform, to register their imported products online. https://ddf.moh.gov.kh/
• The documents required for registration include:

1. Application form,
2. GMP or ISO certificates,
3. A free sale certificate,
4. A letter of authorization,
5. The product’s manual.

Generic drugs registration process in Cambodia

1. The application and the required supporting documentation are sent to DDR.
2. The authorities perform a pre-screening examination to ensure that the application is comprehensive before approving it.
3. Following the pre-screening evaluation, the Subcommittee/committee reviews the whole application and all supporting documentation.
4. The registration and cosmetics department then issues a decision following evaluation.
5. If the authorities find any deficiencies in the application, it might be corrected.