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15 years after the passing of landmark European Commission (EU) regulation to encourage orphan medicine development, the EU is now running a public consultation to take views on revised guidance on how the regulation should operate in practice. Amongst the matters being consulted upon is whether a candidate for orphan drug designation should be required to demonstrate ‘significant benefit’ over not only existing authorised products, but also those prepared in hospital pharmacies. The consultation also seeks views on if, and how, orphan drug designation benefits could be better applied to benefit the development of treatments for low to zero prevalence infectious diseases in Europe that nonetheless pose the potential risk of becoming a serious threat to public health (eg, Ebola).
International Committee of Medical Journal Editors proposes individual patient data sharing
The International Committee of Medical Journal Editors (ICMJE) is proposing that authors must share the anonymised individual patient data underlying clinical trial results published in its member journals.
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.