By S. Siapha Mulbah (Cub Reporter)
The Liberia Medicines and Health Products Regulatory Authority (LMHRA) has conducted a day-long stakeholders’ meeting with the Scientific Advisory Committee and others in the medicine and clinical sector.
The meeting was conducted to highlight and discuss issues concerning clinical trials and some other major issues covering the medicine and health product sector.
According to LMHRA Managing Director, Keturah Smith-Chineh, clinical trial is a most systematic and scientific approach that is new to the African continents most especially Liberia.
She said it is the process that starts with and controls all other activities of medicines usage ranging from the quality, effects, benefits as well as disadvantages and therapeutic connections of all health products in a country.
Over the weekend at the Cape Hotel in Monrovia, the LMHRA boss expressed optimism that the clinical trial regulation will help Liberians and Liberia positively while major health hazard is confronting the world on a daily basis.
“Basically before a medicine comes out to be recognized to treat particular diseases, it has to go through processes that start from clinical trials beginning from animals to humans and the rest of the populations,” she explained.
Madam Smith-Chineh maintained that over the years, the LMHRA has not had a framework regulation or guideline to neither aid nor guide the processes involved in the trials of clinical activities, a situation she said could lead the medical agency into wrongful proceedings.
”Over the years we have not had a particular guide line in the clinical trial processes, and if we do not get a regulation, things will not be done scientifically. So we create the guidelines and regulations to be able to guide us in the process,” she intimated.
According to her the document being made for the public for their own safety, it will be published on the LMHRA website so that all citizens and stakeholders in the medicine and health products areas can take responsibility making sure that before clinical trials come into the country the authority in charge can be reached to safeguard such.
In her presentation, the LMHRA boss maintained that the authority has a group of professionals that are from diverse background forming a team of what is considered Scientific Advisory Committee (SAC) that have been committed to the process of formulating the regulation and will also be doing more to make sure it achieve its goals.
Presenting the Guidelines, LMHRA Manager for Clinical Trials, Juwe Kerkula, outlined several mechanisms that had been put together to solve the old age problem of clinical trials in Liberia.
Dr. Kerkula listed, among several other things, the preconditions for a clinical trial, authorization, inspection, notification of serious adverse events as well as clinical trial reports.
He further narrated administrative sanctions, civil liability and criminal penalty as the consequences for those that will be found violating the regulations of the LMHRA.
