Accelerating regulatory approvals through the World Health Organization collaborative registration procedures

Article type: Research Article

Authors: Caturla Goñi, Mercè

Affiliations: Global Access Regulatory Lead/Regulatory Policy (Africa & WHO), Janssen Pharmaceutica N.V., Beerse, Belgium. E-mail: [email protected]

Abstract: Towards African Regulatory harmonization processes - Accelerating patient access to medicines. The role played by properly functioning regulatory systems towards enhancing access to essential medicines for patients is crucial. This is especially the case in Africa which has seen progressive growth in the regulatory environment. At the center of this growth has been the African Medicines Regulatory Harmonization (AMRH) initiative. This initiative seeks to strengthen regulatory capacity and encourage harmonization of regulatory requirements - with the ultimate aim of expanding access to quality, safe, and effective medicines for patients in need in Africa. A lot of progress has been made during the last years, with initial focus on the East African Community, where harmonization related regulations have already been implemented. The same is now being rolled out in other regions such as West Africa and the Southern African Development Community. Removing bottlenecks and reducing redundancies in regulatory processes that slow access to medicines for patients in need today is critical. In this sense, collaboration between the World Health Organization and relevant stakeholders, including the research-based pharmaceutical industry, on collaborative registration procedures that support fast and efficient review and approval of essential medicines in Africa is essential. African regulatory harmonization offers many benefits to regulatory authorities, patients in Africa and industry alike - and most critically for the protection of public health.

Keywords: Accelerated registration, collaborative registration procedure, joint reviews/assessments, Africa Medicines Regulatory Harmonization (AMRH)

DOI: 10.3233/PPL-160437

Journal: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 109-120, 2016