Module 1 2021

25/06/2021

MEA Regulatory Overview Regulatory Characteristics

● ~ 60 different national regulatory authorities working independently to register medicines across Middle East & Africa ● Guidelines and procedures are not up to international standards and rather administrative ● Regulatory system is not (well) established in many countries e.g. Burundi, Cape Verde, Eritrea ● Many sectors are still not sufficiently regulated i.e. variations, Biologicals, Biosimilars, Pharmacovigilance, Orphan drugs … where requirements mainly depend on experience and direct approach to Health Authorities ● Inadequate resources. However, no full reliance on decisions made by other recognized authorities ● Trend to shift regulatory responsibilities from MoHs to independent authorities e.g. SFDA (Saudi), NAFDAC (Nigeria), SAHPRA (South Africa),

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MEA Regulatory Overview (cont.)

38 Regulatory Characteristics (cont.) ● Company/Site registration is a separate process in many countries (Saudi) and should sometimes precede product registration ● Inspection required by many authorities. PICs recognized by few (Iran) ● Pricing is part of the registration procedure ● MAA and license maintenance should be handled country by country ● Different administrative and technical requirements, process and procedures for medicines registration ● Turkey has taken major steps towards harmonizing its legislation with EU

The Organisation for Professionals in Regulatory Affairs

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