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legislation

This page shows the latest legislation news and features for those working in and with pharma, biotech and healthcare.

Can a post-Brexit UK stay aligned with Europe on clinical research?

Can a post-Brexit UK stay aligned with Europe on clinical research?

At the heart of those considerations is the forthcoming Clinical Trials Regulation (CTR) – new legislation that has been welcomed by the pharma industry, academia and medical charities alike as streamlining and ... And even if the legislation is delayed

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  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    2017. The Regulations state that fundamental revision of the legislation is intended to provide a ‘sustainable regulatory framework for medical devices which ensures a high level of safety and health while ... A key change expressly includes software

  • Biologic or biosimilar: what are prescribers thinking? Biologic or biosimilar: what are prescribers thinking?

    Many companies (eg, from Asia) are unknown, and uncertainties around delivery capabilities and safety legislation creates trust issues.

  • Brexit talks threaten supply of medical technologies Brexit talks threaten supply of medical technologies

    In practice, this would mean drafting legislation that mirrors the new EU rules for diagnostics and devices. ... Legal entities - such as authorised representatives, legal manufacturers and importers - may no longer have a mandate from the UK to address

  • Brexit implications for UK pharma legislation Brexit implications for UK pharma legislation

    Brexit implications for UK pharma legislation. What are the potential options and outcomes of the negotiations? ... Otherwise, further primary legislation will be needed. So, what are the potential options and outcomes in the negotiations?

  • Tightening medical device safety Tightening medical device safety

    The scope of application has also been extended: products outside the scope of the previous legislation are now covered, eg eye contact lens solutions and various kinds of laser equipment mainly

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