Pharmacovigilance Experts Review and Advisory Committee (PERAC)
The Pharmacy and Poisons Board (hereinafter “the Board”) is the National Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board is mandated to protect and promote public health by regulating the pharmacy profession and ensuring access to quality, safe and effective health products and technologies (HPTs).
In furtherance of this mandate, Rule 5 of the Pharmacy and Poisons (Pharmacovigilance and Post-Market Surveillance) Rules, 2022 establishes the National Pharmacovigilance Centre as the Government-recognised national system responsible for coordinating pharmacovigilance and post-market surveillance activities. The Centre is mandated to receive, collate, manage, assess and analyse safety information relating to health products and technologies authorised by the Board, identify safety signals, and communicate regulatory safety information to safeguard public health.
Further, Rule 5(4)(d) of the aforementioned rules provides for the establishment of expert committees to provide technical assistance to the National Pharmacovigilance Centre on causality assessment, risk management and the investigation of pharmacovigilance-related issues. It is pursuant to this provision that the Board established the Pharmacovigilance Experts Review and Advisory Committee (PERAC).
The Committee serves as an independent multidisciplinary scientific and technical advisory body that supports the Board in the assessment of adverse events following the use of health products and technologies, causality assessment, benefit-risk evaluation, signal detection, risk management, and the review of emerging safety concerns. The Committee provides evidence-based recommendations to strengthen regulatory decision-making and contributes to the continuous monitoring of the quality, safety, and efficacy of health products and technologies used in Kenya.
The following are the members of the Pharmacovigilance Experts Review and Advisory Committee appointed to serve for the period 2024–2027.
No | Name | Role | Area of Specialization |
1. | Prof. Faith Apolot Okalebo | Chair | Pharmacology and Health Economics |
2. | Dr. Joseph Kariuki Mbuthia | Vice Chair | Pediatric Infectious Diseases |
3. | Dr. Job Wapang’ana Kisuya | Member | Immunology |
4. | Dr. Eric Guantai | Member | Drug Discovery and Development |
5. | Dr. Peter Omondi Oyiro | Member | Internal Medicine/ Fellowship in Medical Oncology |
6. | Dr. Mutambuki Kimondo | Member | Anatomic Pathology |
7. | Dr. Nereah Achieng Kisera | Member | Vaccinology |
8. | Dr. Clarice Ambale | Member | Pharmacoepidemiology & Pharmacovigilance |
9. | Dr. Nellius Nyambura Njau | Member | Clinical Pharmacy |
10. | Mr. Emmanuel Owino Ochieng | Member | Epidemiology and Biostatistics |
11. | Dr. Rachael Kimani
| Member | Anaesthisiology |
The Board acknowledges and appreciates the commitment, expertise and distinguished service of the members of the Pharmacovigilance Experts Review and Advisory Committee. Through their independent scientific advice and multidisciplinary expertise, the Committee continues to strengthen evidence-based regulatory decision-making and contributes significantly to safeguarding the health and well-being of the people of Kenya.
The Board looks forward to the Committee’s continued support in advancing pharmacovigilance, medicines safety and the protection and promotion of public health.