Regulatory Focus™ > News Articles > 2022 > 1 > Euro Roundup: Swissmedic shortens time limits for reporting foreign safety signals

Posted 27 January 2022 | By Nick Paul Taylor 

Euro Roundup: Swissmedic shortens time limits for reporting foreign safety signals

2907 The Swiss Agency for Therapeutic Products (Swissmedic) has cut the time limits for reporting signals that are classified as emerging safety issues. Under the new rules, marketing authorization holders have five days to report a signal and 15 days to bring the process to its conclusion.
Swissmedic is applying the new limit to emerging issues such as urgent procedures and safety-related referral procedures in the EU. The agency expects companies to report signals immediately, and no later than five days after learning of them if the issues require measures for maintaining drug safety such as immediate public notification or short-notice withdrawal from the market.
The rules give companies up to 15 days to report to Swissmedic “if there are other serious drug risks that are not adequately explained in the product information.” Swissmedic wants companies to use the Signal Notification Form for both initial and closure reports.
Swissmedic Notice
EU publishes final arrangements for new IVDR transition in official journal
The EU has published the revised arrangements for the transition to the full enforcement of the In Vitro Diagnostic Regulation (IVDR). The text is practically unchanged from the draft proposal published by the European Commission in October.
All the key features of the proposal survived review by the European Parliament and the Council, with the changes limited to tweaks to the wording and punctuation. That means IVDR will still take effect on 26 May and devices placed on the market before that date will benefit from a staggered transition that is designed to delay and reduce peak demand for the services of the small pool of notified bodies.
The EU is taking a risk-based approach to the transition timeline. Manufacturers of Class D devices have until 26 May 2025 to get their products certified under IVDR. After that there are annual deadlines for different types of devices that end on 26 May 2028.
EU Regulation
UK grants cancer patients early access to investigational Novartis’ drug
The Medicine and Healthcare products Regulatory Agency (MHRA) has added Novartis’ leukemia drug asciminib to its Early Access to Medicines Scheme (EAMS), clearing patients to start receiving treatment before it is approved.
MHRA is making the STAMP inhibitor available to adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase without T315I mutation who have previously received two or more tyrosine kinase inhibitors. The indication limits asciminib to a subset of patients with chronic myeloid leukemia in the UK, where around 830 new cases occur each year.
To support the introduction under EAMS, MHRA has published treatment protocol information on the pharmacovigilance system and information for healthcare professionals. The US FDA approved asciminib in October; it is marketed under the trade name Scemblix.
Press Release, MHRA Notice
Other news:
The European Directorate for the Quality of Medicines (EDQM) is seeking feedback on draft monographs. The 12 draft monographs cover molecules including the antipsychotic pimozide and chronic obstructive pulmonary disease drug salbutamol sulfate. EDQM is accepting feedback on the monographs, which will be legally binding once adopted, until 31 March. EDQM Notice


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you