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.
• Pharmaceutical regulation in Cambodia is overseen by the Ministry of Health through the Department of Drugs and Food (DDF Cambodia), which serves as the primary Cambodia regulatory authority for pharmaceutical products.
• 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.
• OMC Medical supports Cambodia drug product registration by helping manufacturers comply with Cambodia drug registration guidelines issued by the Cambodia drug regulatory authority.
• 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 for Cambodia Drug Product Registration: 

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

Cambodia Drug Product 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.