MHRA to relaunch the Innovative Licensing and Access Pathway (ILAP) pathway in Q1 2025

Last updated: 9 April 2025 To view updates, click on the ‘+’ sign below: The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The…

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Swissmedic- Changes to the guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

The processes for the following have been optimised: Normally, if the criteria for an FTP or a temp.auth. / temp.AI cannot be conclusively evaluated following the assessment of the submitted documents by Swissmedic, an Accelerated Application HeAring (AAA) usually takes…

Read MoreSwissmedic- Changes to the guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products

Learning from Case Law: Preliminary ruling on Case C‑181/24 by the CJEU on the interpretation of Articles 3(b) and (d) of SPC Regulation (EC) No 469/2009

This post is an attempt to present the details of a preliminary ruling by the CJEU on Case C-181/24 (Genmab A/S vs Budapest High Court) on the interpretation of Articles 3(b) and (d) of Supplementary Protection Certificate (SPC) Regulation (EC) No 469/2009, in…

Read MoreLearning from Case Law: Preliminary ruling on Case C‑181/24 by the CJEU on the interpretation of Articles 3(b) and (d) of SPC Regulation (EC) No 469/2009