All Insights
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Life Sciences and Healthcare
Approval of insomnia app for use in the NHS offers a case study for digital health developers
Opportunities are available for those that navigate the regulatory system and provide evidence of their products' efficacy and performance
Life Sciences and Healthcare
Medical device, clinical trial and safety rules reforms could boost UK life sciences
As the economy falters and NHS waiting lists grow, 2021 legislation offers wide powers to reform product rules and spur
Life Sciences and Healthcare
New WTO Covid-19 vaccine IP waiver proposed
A new vaccine IP waiver proposal has been published by the WTO Director-General following informal negotiations between the EU, India
Life Sciences and Healthcare
Italy is finally poised to get a law on transparency in the healthcare sector
Sunshine Act will oblige Italian pharmas to respect the obligations of transparency regardless of industry codes The Italian Parliament is
Digitalisation
Digital Regulation Cooperation Forum launches a UK hub for expertise
A network of UK regulators' research portal will bring together work on the regulation of digital markets and is likely
Life Sciences and Healthcare
The transfer of Data of non-profit clinical trials to pharmaceutical companies is now allowed in Italy
Previous restrictions on data transfer are lifted, enabling more investment - some clarification on practical issues is awaited In the
Life Sciences and Healthcare
Compassionate Use in Europe
As European countries implement compassionate use programmes in different ways, we offer a guide to the different approaches taken within
Intellectual property
European Commission proposes harmonisation of patent law with unitary SPCs and single procedure for grant
The European Commission has launched a call for evidence on its proposal to create a unitary supplementary protection certificate and/or
Life Sciences and Healthcare
Farmindustria releases updated Code Of Ethics
Italy's association for pharmaceutical companies has amended its Code of Ethics with 4 new articles on PSP and on the
Life Sciences and Healthcare
Is Italy's new law on rare diseases a starting or end point?
Pharmaceutical companies will need to take note of new rules that include funding for research and tax incentives After a
Life Sciences and Healthcare
2021 Life Sciences Patent Case Review
The UK Patents court has had an active year – we review 18 of the principal cases for the sector
Life Sciences and Healthcare
Medical device advertising in Italy: is authorisation by the Ministry of Health still required?
Italian Ministry of Health departs from harmonised EU regulatory framework on advertising medical devices by continuing authorisation regime
