News flash | UK additional consultation & innovative pathway

Date d'envoi: mai 26, 2023

Daniëlle Motta, MSc "Notre équipe Global Registration opère partout dans le monde accéder aux différents marchés. Ensemble, nous déterminons votre stratégie réglementaire globale et une feuille de route cohérente pour rencontrer les exigences locales, obtenir l'enregistrement de vos produits et maintenir votre documentation technique à jour."

On the 26^th of May, there are two updates from the Medicines and Healthcare Products Regulatory Agency (MHRA).

A life science growth package. The update addresses the growth potential of the UK market by increasing investment. The update also confirms that the MHRA will launch an additional consultation into international recognition of medical devices by October. It is expected that the consultation will shed light on the potential approach for the domestic assurance route to obtain approval for the GB market. The MHRA will also be consulting on guidelines supporting their ambition to maintain patient
safety, enabling and encouraging innovation, and risk-proportionate regulation.

Chancellor reveals life sciences growth package to fire up economy: https://www.gov.uk/government/news/chancellor-reveals-life-sciences-growth-package-to-fire-up-economy
Innovative Devices Access Pathway (IDAP). The pilot is set for launch later in 2023 and should facilitate the development of innovative medical technologies through a multi-partner support service, including targeted scientific advice. This pilot will allow enhanced opportunities for engagement. The aim is to help take the uncertainty out of the route to access, bringing innovative technologies to patients that can transform health outcomes.

New regulatory pathway set to support safe patient access to innovative medical technologies: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies

If you have additional questions please send them to globalreg@qservegroup.com.

Partager cet article

Besoin d’informations complémentaires?

Des questions ou un besoin d’informations complémentaires? N’hésitez pas à nous contacter.

Contactez-nous

Centre de connaissances

Comment pouvons-nous vous aider? Contactez-nous