The Pharmacy and Poisons Board (PPB) has fully automated its services, making it the first national drug regulatory authority in Africa to automate clinical trial registry process among other services.
According to PPB Senior Deputy Chief Pharmacist and Deputy Registrar, Dr Fred Siyoi, the automation will reduce delays in service delivery and increase the board’s capacity to stem backstreet pharmaceutical practice.
Initially, it would take applicants up to a month to get a practicing license but with the automation, it takes the board 72 hours to complete the process.
“The automation project has also boosted revenue collection measures and improved industry surveillance mechanisms. Payments to the board are now done fully through electronic money transfer services,” said Dr Siyoi.
According to Dr Siyoi, Kenya now joins Medicines Control Council of South African (MCC) as the only pharmaceutical regulatory authorities in the continent to receive submissions of drug registration dossiers online, commonly referred to as Electronic Common Technical Document (E – CTD).
Services offered at the PPB such as license renewals, payments, clinical trials, students’ registration, trade, inspection and verification of professionals have now moved online.
Through the automation, Kenya is now a regional center of regulatory excellence for pharmacovigilance, a platform that tracks and reports adverse effects licensed drugs may have on patients. Regulatory authorities in countries such as Zimbabwe, Uganda and Zambia are using PPB as a regulatory benchmark in the pharmaceutical industry.
Dr Siyoi said, however, the automation process, which began in 2007 had been faced with glitches considering that the board had initially planned to automate all services by close of 2015.
He said a budget hitch derailed the process, with the Board only achieving about 80 per cent service automation at close of the 2015 deadline.
“We had an initial budget of Sh6million but after the process was mapped, Sh240 million was required. We could not get that at a go and we had to do resource mobilisation,” said Dr Siyoi.
The US Centre for Disease Control aided in paying the system developers.