NAIROBI, KENYA: The pharmaceutical sector is set to benefit from wider access to the market following a plan by the East African Community (EAC) States to set up a single regulatory agency for drugs.
The regulator is expected to cut time and costs of evaluations and approvals of medicines and medical devices, allowing drug firms to access the 160 million-strong EAC market with ease.
Currently, new medicines have to be evaluated by separate regional regulatory agencies before being allowed into the market. Under the new plan, once a single agency approves a drug, it can be sold to all EAC States without national evaluations.
“The focus of the proposed agency will be to regulate selected medicines and medical devices which are complex in nature and require special knowledge and expertise to authorise their use by the population,” said Dr Felista Chepwogen of the Pharmacy and Poisons Board.
He also doubles as EAC Medicines Regulatory Harmonisation project official. “The timelines for review and registration of medicinal products entering regional level have been prolonged primarily due to lack of institutional structures that have legal mandate to handle and process applications.”
The select medicines may include vaccines, genetically modified products, medical devices, medicines for rare diseases, high-risk food products among others. A secretariat within EAC’s department of Medicines and Food Safety will coordinate the joint activities in preparation for a single medicine and food safety agency.
This is expected from the year 2018. The proposed agency is modelled on the European Medicines Agency which regulates certain medicines for 28 European Union countries with a combined population of 510 million.
Since 2015, national drug regulators of EAC, except Burundi and South Sudan have been implementing joint drug evaluation and market authorisation procedures, including joint inspections of drug manufacturing sites.
Under the joint evaluations, firms seeking to introduce new medicines to the region, still have to submit applications and pay fees to all countries individually.
The proposed creation of a single regulatory agency seeks to eliminate duplication that so that applications are made to one institution only. “The joint evaluations of medicines have minimised duplication of efforts and saved resources. The regime has resulted in faster registration timelines for jointly assessed dossier applications. It has also improved capacity for the regulators and the pharma industry,” he said.
Dr Chepwogen denied claims of undue delays within the existing joint regional evaluation of medicines within EAC, saying they are often caused by pharma companies that don’t respond to regulatory queries faster.