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ICH - Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2
19th October 2022The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.
MHRA - Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety
19th October 2022Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety. Consultation description The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients. We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety. Your Participation You can participate in this consultation anonymously but if you choose to provide your email address, we will add you to our mailing list to offer you future opportunities to hear about or get involved in our work. This questionnaire will take approximately 20 minutes to complete, or longer if you wish to offer additional comments. Please note that you do not have to answer every question and compulsory questions are clearly marked. Ways to respond Respond online
MHRA - MORE Registrations - user reference guide A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
19th October 2022MORE Registrations - A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
MHRA - Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools
19th October 2022Mental health funding of £1.8m welcomed by MHRA and NICE to explore regulation of digital mental health tools
MHRA - Software and AI as a Medical Device Change Programme
19th October 2022Software and AI as a Medical Device Change Programme
MHRA - Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems
19th October 2022Unique opportunity for healthcare professionals to influence future MHRA safety communications and safety reporting systems
MHRA - annual accountability review minutes
19th October 2022The minutes of the ministerial annual accountability review of the Medicines and Healthcare products Regulatory Agency (MHRA).
MHRA - Quarterly Summary Reports added to Medical Device Guidance
29th September 2022Quarterly Summary Reports added to Medical Device Guidance
MHRA - Advertising and Promotion Section added to NIMAR
29th September 2022MHRA have added an 'Advertising and Promotion' Section added to NIMAR
MHRA - first new UK Approved Body to certify medical devices since Brexit appointed
29th September 2022MHRA appoints first new UK Approved Body to certify medical devices since Brexit
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