UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough therapies in high-impact areas

Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…

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A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

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Last updated: 11 December 2025 On 26 April 2023, the European Commission published its pharmaceuticals reform proposal for more accessible, affordable and innovative medicines. This was covered in a previous post. This post is an attempt to taker a closer…

Read MoreA closer look at some aspects of the proposed revision of the EU pharmaceutical legislation

European Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines

Last updated: 11 December 2025 To view updates, click on the ‘+’ sign below. The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and…

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Progress with amendments to the EU variations regulation and guidelines

Last updated: 4 December 2025 To view updates, click on the ‘+’ sign below. This post provides information on the ongoing changes to the EU the variation Regulation (EC) No 1234/2008 and guidelines. The commission delegated regulation (EU) 2024/1701 Timeline of…

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National Competent Authorities to launch a fast-track approach for the authorisation of multinational clinical trials in the EU/EEA

On 27 November 2025, a large number of National Competent Authorities (NCAs) and Ethics Committees committed to test a coordinated fast-track approach for evaluating multinational clinical trials. About the FAST-EU (Facilitating and Accelerating Strategic Trials) initiative When is the FAST-EU…

Read MoreNational Competent Authorities to launch a fast-track approach for the authorisation of multinational clinical trials in the EU/EEA