Update on new guidance by the EMA – Advanced Therapy Medicinal Products

[{“id”:”ed308lwb93qf2″,”elType”:”container”,”settings”:{“flex_direction”:”column”},”elements”:[{“id”:”5820cba”,”elType”:”container”,”settings”:[],”elements”:[{“id”:”_ed308lwb93qwo”,”elType”:”widget”,”settings”:{“editor”:”The European Medicines Agency (EMA) yesterday released a questions and answers (Q&A) document specifically in relation to Advanced Therapy Medicinal Products (ATMPs), clarifying the circumstances in which an exemption from the normal requirement to re-test batches of medicinal products imported from third countries into the EU may be granted. According to the Q&A document, an exemption may be granted if the product has been manufactured and tested in a country that has a relevant mutual recognition agreement (or equivalent arrangements) on Good Manufacturing Practice (GMP) with the EU; and if the conditions laid down in paragraph 11.17 of the EU GMP Guidelines for ATMPs (Guidelines) are met. The Q&A document emphasises that the exemption is ‘exceptional’ and ‘primarily foreseen for imported patient-specific ATMPs (e.g. autologous product)’ and strongly advises applicants intending to request an exemption to proactively consult with EMA early in product development.”,”drop_cap”:”no”,”typography_typography”:”custom”,”typography_letter_spacing”:{“unit”:”px”,”size”:”0″},”typography_font_size”:{“unit”:”px”,”size”:”18″},”size”:”18″,”typography_font_weight”:”400″,”typography_line_height”:{“unit”:”px”,”size”:”28″},”title_color”:”#4b2771″,”text_color”:”#4b2771″,”color”:”#4b2771″,”align”:”start”},”widgetType”:”text-editor”}],”isInner”:false}],”isInner”:false}]