Pharmacovigilance of biotherapeutic medicines – case studies
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The ECOWAS Joint Assessment Procedure is a collaborative initiative among 15 National Regulatory Agencies in West Africa that ensures harmonized and streamlined market authorization of medical products across the region. This infographic provides an overview of key steps and timelines applicants need to bear in mind during the Joint Assessment Procedure.
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Registration of multiple manufacturing sites in one product license
In a joint position paper, EFPIA, IFPMA and Vaccines Europe urge all countries to adopt a ‘multiple-site-to-one-license’ approach for registrations, in line with WHO and other guidelines. This will result in a reduction of duplicate work for all stakeholders, help to build agility and speed in supply chain management and improve patient access to medicines and vaccines.
Read moreFee system for regional joint assessment procedures in Africa
This joint position paper covers the perspective from industry on the proposed fee system for regional joint assessment procedures in Africa.
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