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Other Agencies

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Other Agences
Updates - December 2023 - January 2024
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Medicines: Marketing Authorization Holders' Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing

Marketing Authorization Holders should review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present.

Updated information following the passing of the deadline for the submission and. additional guidance about lifecycle management is provided.

Project Orbis

Project Orbis is a program to review and approve promising cancer drugs helping patients access treatments faster.

The MHRA has recently updated its guidance in relation to Project Orbis and ILAP. There is no longer a requirement to obtain an Innovation Passport as part of the Project Orbis program.

Notify the MHRA about a Clinical Investigation for a Medical Device

Added template for submitting Quarterly Summary Reports.

Register Medical Devices to Place on the Market

Updates are as follows:

  • Updated 'Account Management Reference Guide' & 'Device Registration Reference Guide'

  • Updated video for 'Registering a custom-made medical device'.

Published reminder concerning legislation requirements for custom-made devices.

Implementation of Medical Devices Future Regime

This document provides an update on the intended timelines to implement the future core regulations.

Added 'Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices' and information about 'future core regulations'.

Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland

Updates are as follows:

  • Updated 'Register of Written Confirmations for UK active substance manufacturers'.

  • Updated the Written Confirmation PDF

Updated Requirements for Dealing with Potential Nitrosamine Impurities in Medicinal Products

As communicated at the information event on 20 September 2023, Swissmedic continues to apply the acceptable intakes published by EMA. Marketing authorization holders are required to perform a risk-based evaluation of their medicinal products and synthetic active substances with the potential for nitrosylation and to submit the results to Swissmedic.

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