Marie Manley, partner at law firm Sidley Austin, and associates, look at how UK and EU life sciences are responding to the regulatory requirements presented by Covid-19.
Regulations
Covid-19 presents an unprecedented challenge to the global life sciences industry. The UK and EU regulators have worked to provide up-to-date guidance in response to the evolving crisis, as well as to support research and development (R&D) that they hope will contain the impact of the spread. The regulators must continue to coordinate in order to maximise clarity in this uncertain environment in which the far-reaching consequences of the pandemic are only just starting to manifest.
This article provides guidance as to the response of UK and EU regulators so far in the areas of clinical trials, inspections and the continuity of supply in medicinal products and medical devices, as well as the proposed postponement of implementation of the medical device regulation (MDR) and in vitro diagnostics regulation (IVDR). We also summarise key R&D initiatives at a UK and EU level.