The pharmaceutical division is set to profit by more extensive access to the market following an arrangement by the East African Community (EAC) States to set up a solitary regulatory agency for drugs. Drug firms can then access the 160 million strong EAC market easily as the agency is expected to reduce time and expenses of assessments and approvals of medicines/medical devices.
As of now, new medicines must be assessed by different regional regulatory authorities before being permitted into the market. Under the new arrangement, once an agency approves a medication, it can be sold to all EAC States without national assessments. Dr. Felista Chepwogen from Pharmacy and Poisons Board said, “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.”
He similarly is appointed as EAC Medicines Regulatory Harmonization Project official. He stated that the timelines for audit and enlistment of medicinal products entering regional level have been drawn out principally because of absence of institutional structures that have legit command to deal with and process applications.
The select medicines may incorporate immunizations, vaccines, genetically modified (GM) products, medical appliances, pharmaceuticals for rare ailments, high-risk food items among others. A secretariat inside EAC’s division of Medicines and Food Safety will organize the joint activities for development of a single pharmaceutical and food safety office. This is expected from 2018 onwards. The proposed agency takes inspiration from the European Medicines Agency which regulates certain pharmaceuticals for 28 European Union nations with a total populace of 510 million.
Since 2015, national drug controllers/regulators of EAC, with the exception of Burundi and South Sudan have been actualizing joint drug assessment and market authorisation protocols, including joint reviews of drug manufacturing sites. Under the joint assessments, firms trying to introduce new medicines within the area, still need to submit applications and pay expenses to all nations separately.
The proposed formation of a solitary regulatory agency looks to dispose of duplication with the goal that applications are made to one organization itself. Dr. Chepwogen remarked, “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 repudiated claims of undue slow-downs within the current joint regional assessment of medicines in EAC, saying they are frequently caused by pharmaceutical organizations that don’t react to regulatory questions speedily.