DDReg Pharma

Pharmacovigilance Services in Kenya

The National Pharmacovigilance Centre (NPC) based at the Pharmacy and Poison Board, under the Ministry of Health, oversees pharmacovigilance activities including adverse drug reactions (ADRs) and poor-quality medicine reporting in Kenya. Under the NPC, the Pharmacovigilance Risk Assessment and Advisory Committee (PRAAC) is responsible for assisting in the technical aspects such as the causal relationship between the suspected ADR and the suspected drug. In Kenya, it is the responsibility of the general public, the National Medicines Regulatory Authorities (NMRAs), healthcare providers across all levels of the healthcare system as well as public health programs (PHPs), and the pharmaceutical industry, including marketing authorization holders (MAHs) to report all ADRs. All except MAH can submit adverse drug reactions reports through the various forms developed by NPC: Adverse Event Following Immunization (AEFI), Suspected Adverse Drug Reaction Reporting Form (SADR), medical devices incident reporting form, medication error reporting form, Poor Quality Medical Products and Health Technologies (PQMP), and adverse transfusion reaction form. MAHs can submit an ADR report using the international CIOMS form. In addition to this, it is a must to have a QPPV person who will be the single point of contact on behalf of the MAH regarding the pharmacovigilance of the marketed products. Also, Kenya has a county investigation team with a county Vigilance focal person who receives ADR reports from local hospitals, physicians, and the public and reports them to NPC.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Kenya that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
QPPV Services
PV Audit & Compliance
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