Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
24 October 2023 – the MHRA published the guiding principles for the use of predetermined change control plans for machine learning-enabled medical devices.
In this document, FDA, Health Canada, and MHRA jointly identified 5 guiding principles for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re-training risks are managed.
Clinical Trials for Medicines: Apply for Authorization in the UK
12 October 2023 – the MHRA updated the guidance on how to apply for a clinical trial in the UK.
The New Notification Scheme enables a more streamlined and risk-proportionate approach to processing Clinical Trial Authorizations (CTA) for “initial” applications and only applies to Phase 4 and certain Phase 3 clinical trials deemed to be of lower risk and does not include CTA applications for first in human (FIH), Phase 1 or Phase 2, or amendments at this time.
Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries)
8 November 2023 – the Swissmedic published updated guidance on RMP ICHE2E information for submission HMP
The guidance document “RMP ICH E2E Information for submission HMP” has been fully revised. The most important change concerns the obligation to submit RMPs, which now only applies to first authorization applications for new active substances and their indication extensions.
The changes take effect on 1 November 2023.
Amendment to the Medical Device Ordinance (MedDO)
1 November 2023 – the Swissmedic published the implementation guides of the revisions to the MedDO.
The Federal Council has decided to amend the Medical Devices Ordinance (MedDO) to improve the safety of products without an intended medical purpose (media release dated 29 September 2023). Switzerland has adapted its MedDO for these products in line with the EU requirements (Implementing Regulation 2023/1194) taking into account the new transitional periods. The required amendments to the MedDO have been approved and will enter into force on 1 November 2023.
Modifications to Guidance Document, Formal Requirements
1 October 2023 – the Swissmedic published clarification on submission via eDOK and eCTD for co-marketing medicinal products.
Submission of complete identical document sets for eDOK and eCTD has been clarified with regard to co-marketing medicinal products. In addition, the submission deadline for variations without assessment after implementation for VMPs has been extended from a maximum of 1 month to a maximum of 60 calendar days. The revised guidance document Formal requirements is valid with effect from 1 October 2023.
Software and Artificial Intelligence (AI) as a Medical Device
25 October 2023 – the MHRA published updated guidance on software and AI as a medical device.
This guidance provides information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
The latest update added the MHRA, FDA and Health Canada's 5 guiding principles for the use of PCCPs to the AI section.
Apply for a License to Market a Medicine in the UK
19 October 2023 – the MHRA published the updated guidance on the application of a market licence of a medicine in the UK.
The most recent update added the following:
Checklist and abstract for bioequivalence studies and/or biowaivers
Checklist for product information', for established active substance MAAs within scope.
International Recognition Procedure
3 October 2023 – the MHRA published updated guidance on how to use the new procedure for medicinal licensing applications.
The MHRA has created a new international recognition route for medicines utilizing pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States. This new framework will support patients in the UK with expedited access to safe and effective medicines that have been approved by trusted regulatory partners. From 1 January 2024, international recognition will sit alongside the MHRA’s current national procedures.
The latest updates includes additional guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle.
Swissmedic Confirmed as a World Health Organization (WHO) Listed Authority
1 November 2023 – the Swissmedic announced the WHO listed Swissmedic as a WHO listed authority on 30th October 2023.
The WHO listed Swissmedic as a WHO Listed Authority (WLA) on 30th October 2023. Regulatory authorities that are listed as WLAs comply with international standards and practices and have been assessed by the WHO. In this way, the World Health Organization aims to ensure that only safe, effective and high-quality medicinal products are on the market worldwide.
Changes to the Guidance Document, Mobile Technologies and the Related Form
1 October 2023 – the Swissmedic published changes to the guidance document, Mobile technologies and its related form.
Training documents according to the most recently approved RMP are now considered to be “information required by therapeutic products legislation.” The form has been amended accordingly. The materials to be submitted for other training materials classified as “additional information” have been clarified. The revised Mobile technologies guidance document and form are valid with effect from 1 October 2023.