World self-medication industry
The world federation promoting better health through responsible self-medication
NGO in official relations with the World Health Organization

Report from the WSMI Task-Force on Product Modernization


The WSMI ‘Task Force on Product Modernisation’ (TF) was formed in 2009 with the mandate to review ways to address the increasing regulatory challenges to OTC ingredients, particularly older substances. Since the publication of the OTC Benefit-Risk Framework (see our news item of November 2011) the WSMI Task Force has supported member associations and companies in a programme of outreach to Regulatory Authorities around the world, discussing the new Tool. Conferences, meetings and discussions have been held with the European EMA and individual European Medicines Agencies, the US FDA, Health Canada, the TGA in Australia, Medsafe in New Zealand and others. Future meetings are planned, such as a Round Table on OTC Benefit Risk with the Chinese SFDA in Beijing later this month, and a follow-up to the successful AESGP Workshop with the Heads of EU Medicines Agencies in Copenhagen in February this year in collaboration with the Irish Medicines Board for Dublin in January 2013. Overall, the OTC Benefit-Risk Framework has been positively received and there are signs of formal adoption – for example, the MHRA in the UK has incorporated the Framework into the latest set of switch guidelines (‘How to Change the Legal Classification of a Medicine in the UK’).

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Brian McNamara New Chair of WSMI

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