MHRA ramps up assessment capacity for in-vitro diagnostic devices
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the designation of UL International UK Ltd as an Approved Body.
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EC adopts proposal to allow more time to certify medical devices
Fears of a shortage of medical devices have led the European Commission (EC) to adopt a proposal to extend the transition period to new rules under the Medical Devices Regulation. The proposal was made at the EPSCO Council meeting on 9 December 2022 by EU health ministers.
EMA reminder that clinical trials must use CTIS
The European Medicines Agency (EMA) has issued a reminder that from 31 January 2023 clinical trial sponsors must use the Clinical Trials Information System (CTIS) for initial trial applications.
Challenges and Trends in Medical Affairs
Medical affairs is an increasingly complex discipline. It is vital that the team is highly trained and able to adapt to an evolving environment, liaising effectively with stakeholders to communicate value and bring new treatments to the market. Read on to discover some of the challenges and trends affecting the sector.