On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation emea_strap_url_cmyk_rev_en_std_cent.eps MASTERof the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced by the update is a possibility for the EMA to disclose clinical data which, although submitted to the EMA before 1 January 2015, was relied on in marketing authorisations submitted after that date.
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Source: Lexology – Hogan LovellsElisabethann Wright and Elinor Pecsteen