Is Khmer-language translation required for adverse event reports to the DDF?

No. The Department of Drugs and Food (DDF) pharmacovigilance guidance states that translation into Khmer is not required for adverse event reports. Registration holders may submit adverse drug reaction reports in English through communication channels such as email, telefax, letter, or phone to the Pharmacovigilance Center of Cambodia.

Should registration holders wait for certainty before reporting suspected ADRs?

No. Cambodia pharmacovigilance guidance states that reporters should not wait until a causal relationship between a drug and an adverse event is proven or disproven. If a suspected adverse reaction is identified, it should be reported. In doubtful situations, it is better to report the event rather than delay reporting.

Must package insert changes be submitted with PSURs in Cambodia?

Yes. The Department of Drugs and Food requires registration holders to submit consequential variations, including package insert changes, at the same time as Periodic Safety Update Reports. Safety-related labelling updates identified during PSUR preparation should be submitted as formal variation applications together with the PSUR submission.

What is the role of Cambodia’s drug regulatory authority in pharmacovigilance?

Cambodia’s Department of Drugs and Food oversees pharmacovigilance by collecting adverse drug reaction reports, evaluating safety data, and implementing regulatory actions when necessary to protect public health and ensure the safe use of medicines.

Pharmacovigilance Services in Cambodia

Your Local Pharmacovigilance Partner for Drug Safety in Cambodia

DDReg provides pharmacovigilance services in Cambodia for pharmaceutical and traditional medicine registration holders. Our team operates local PV systems for foreign MAHs, manages adverse event reporting to the DDF Pharmacovigilance Center of Cambodia, prepares PSURs with simultaneous labelling variations, coordinates WHO Programme submissions, and delivers pharmacovigilance outsourcing Cambodia mandates across the full product lifecycle.

Cambodia Pharmacovigilance Framework

The Ministry of Health (MoH) governs pharmaceutical regulation in Cambodia through the Department of Drugs and Food (DDF). Within the DDF, the Pharmacovigilance Center of Cambodia receives and manages all adverse drug reaction reports from registration holders, healthcare professionals, and consumers. The Center collaborates with the World Health Organization and the WHO Collaborating Center for International Drug Monitoring (Uppsala Monitoring Center), contributing Cambodian safety data to the global VigiBase database.

Cambodia operates a National Pharmacovigilance System specifying roles of registration holders, medical institutions, healthcare professionals, and consumers. The system receives reports via email, telefax, letter, or phone call. Registration holders should report suspected ADRs without waiting for certainty of causal link in doubtful cases, it is better to report than not to report. Lack of efficacy reports are also reportable to the DDF. Translation into Khmer is not required for ADR reports. Registration holders must submit consequential variations simultaneously with PSUR submissions.

Pharmacovigilance Outsourcing Cambodia - DDReg Services

+ Local PV System and DDF Reporting
- Cambodia Local PV Contact: Designated contact for DDF Pharmacovigilance Center communications; manages registration holder obligations; coordinates with local pharmacist or pharmaceutical company authorised representative
- ADR Processing: Individual case triage, causality assessment, narrative writing; suspected ADR reporting to Pharmacovigilance Center of Cambodia; cases entered into National Pharmacovigilance Database
- DDF Adverse Event Reporting: Submission via email, telefax, letter, or phone call; follow-up information provided on DDF request; reporting in doubtful cases encouraged per DDF guidance
- Lack of Efficacy Reporting: Life-threatening infections where lack of efficacy due to newly resistant strains reported to DDF; judgment applied per DDF guideline on reportability
+ Drug Safety Services Cambodia - PSURs and Variations
- PSUR Preparation: Periodic Safety Update Reports prepared per international standards; quality of evidence assessed; benefit-risk analysis included
- Simultaneous Variation Submission: Package insert changes and other consequential variations submitted simultaneously with PSUR per DDF requirement; integrated PSUR-variation coordination
- WHO VigiBase Contribution: Cambodian ICSR data contributed to WHO global database through Pharmacovigilance Center collaboration; Uppsala Monitoring Center coordination
- Post-Marketing Studies: Systematically solicited adverse event processing from post-marketing surveillance programmes; causality assessment where determination difficult
+ Healthcare Professional and Consumer Reporting Coordination
- Spontaneous Report Management: DDF encourages healthcare professionals, retail pharmacists, and consumers to report suspected ADRs; registration holder coordinates follow-up where reporter identified
- Literature Surveillance: Medical and scientific literature screening for Cambodian and regional reportable cases; completeness verification before DDF submission
- Quality Management: Pharmacovigilance Center checks reports for completeness; registration holders provide complementary and follow-up information on DDF request

Cambodia Pharmacovigilance Reporting Requirements

Obligation	Requirement	Authority
Suspected ADR reporting	Report suspicions without waiting for certainty; doubtful cases should be reported	DDF Pharmacovigilance Center
Lack of efficacy reporting	Report life-threatening infections with newly resistant strains; apply judgment per DDF guidance	DDF Pharmacovigilance Center
PSUR submission	Per DDF registration requirements, include quality of evidence assessment	DDF Pharmacovigilance Center
Simultaneous variations with PSUR	Package insert changes and consequential variations submitted with PSUR	DDF Registration and Cosmetics Bureau
Follow-up information	Provide complementary information on DDF request	DDF Pharmacovigilance Center
WHO VigiBase contribution	Cambodian safety data contributed via Pharmacovigilance Center	WHO Programme (voluntary)

Pharmacovigilance Company in Cambodia - DDReg Expertise

DDF Pharmacovigilance Center and WHO Programme Coordination

The Pharmacovigilance Center of Cambodia operates as both the national ADR receiving centre and the WHO Programme partner contributing to VigiBase. DDReg manages dual reporting mandatory DDF submissions for Cambodia regulatory compliance and voluntary WHO Programme contributions through the Pharmacovigilance Center. This coordination strengthens signal detection while ensuring Cambodia-specific reporting obligations are met within DDF timelines.

Simultaneous PSUR and Variation Management

Cambodia requires registration holders to submit consequential variations including package insert changes simultaneously with PSUR submissions. DDReg coordinates integrated PSUR-variation workflows, ensuring labelling updates identified during safety review are prepared as formal variations and submitted alongside the PSUR to the DDF Registration and Cosmetics Bureau. This prevents the sequential submission delays that arise when PSURs and variations are managed separately.

Report in Doubtful Cases - DDF Guidance Adherence

DDF pharmacovigilance guidance explicitly encourages reporting suspected ADRs without waiting for certainty of causal link. In doubtful cases, it is better to report than not to report. DDReg applies this low-threshold reporting standard to all case triage decisions, ensuring suspected ADRs reach the DDF Pharmacovigilance Center even where causality is uncertain. This approach aligns with Cambodia's national system goal of maximizing signal detection through comprehensive spontaneous reporting.

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