Group photo of participates during the launch of Kenya Regional Medicine Regulatory Harmonization Project on 22th October 2018.Pharmacy and Poisons Baord, member Dr. Rugendo Birichi address delegates during the launch of Regional Medicine Regulatory Harmonization Project 22 October 2018.


Government launches new project to improve drug safety

Nairobi, KENYA, October 22, 2018 –  The Government today launched a new project to improve drug safety in the country.

The Regional Medicine Regulatory Harmonization (PROFORMA) project was launched by the Chief Administrative Secretary for the Ministry of Health, Dr. Rashid Aman at a Nairobi hotel.

Dr. Rashid was who was represented by the Pharmacy and Poisons Board member, Dr. Rugendo Birichi, said PROFORMA grant is a joint venture between experts from academia, National Medicines Regulatory Authorities (NMRAs) and WHO-collaborating centers in pharmacovigilance and Regional Centers of Excellence (RCOREs).

He said the government is committed to provide Kenyans with safe, quality and effective medical products and health technologies to safeguard their health and hence the urgent need to develop and strengthen the pharmacovigilance system for patient safety.

The project aims to strengthen the national Pharmacovigilance (PV) infrastructure and post-marketing surveillance systems by forging partnerships between local academic institutions and national medicine regulatory authorities leveraging on existing structures.

Dr. Rashid said the increasing number of clinical trials and the large-scale mass drug administration and immunizations programs being deployed through public health programmes underscores the urgent need to monitor the safety of the patient.

He remarked that the country has made substantial progress in safeguarding the medical products used across the country through the board, Pharmacy and Poisons Board.

“Kenya has made substantial progress in pharmacovigilance with support from the country’s development and implementing partners such as World Health Organization (WHO) and Management Sciences for Health, and is now the 98th member of WHO drug monitoring program under Uppsala Monitoring Centre since May 2010,” he said.

In May 2014, Kenya was nominated by NEPAD agency as a Regional Centre of Regulatory Excellence (RCORE) in pharmacovigilance in Africa, providing an opportunity for other countries to learn from Kenya.

He also acknowledged that although access to medicines in Africa has seen a steady increase, there is still inadequate regulatory capacity to process new drug registration and monitoring drug safety profiles which remains a challenge in Low Medium Income Countries.

“Lack of skilled manpower to lead and manage the regulatory pharmacovigilance process to monitor public safety, and absence of post-marketing surveillance system remains a major gap in the sub Saharan Africa,’ he said.

During the event the Pharmacy and Poisons Board, Chief Executive Officer, Dr. F.M. Siyoi thanked all stakeholders for their financial and technical support in improving medicines safety in the country. “PROFORMA Project has come at the right time when Kenya is geared towards attainment of Universal Health Coverage,’ he said.

PROFORMA coordinator, Prof. Eleni Aklillu said that they aim to strengthen the national pharmacovigilance infrastructure and post-marketing surveillance system by forging partnerships between local academic institutions and national medicine regulatory authorities by using existing structures in Ethiopia, Kenya, Tanzania, and Rwanda.

“Our main objective is to strengthen clinical trial regulator, post marketing surveillance system and pharmacovigilance infrastructure,” she said.

Pharmacovigilance is the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.