Regulatory Updates
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ICH Readies new guidance
The Assembly finalised its rules of procedure, which reflect the new emphasis on clearer governance, transparency and openness in the operation of the reformed ICH, and will be published shortly. Key advances for public health…
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Fast-track drug approval for unmet medical needs in Europe
The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorisation, two key tools in the European legislation to accelerate patients’ access to medicines that address unmet…
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Latest EMA-HTA meeting minutes
The EMA has published the minutes of its face-to-face meeting with the EUnetHTA (European Network for Health Technology Assessment) which was held on 8 May 2015. There were in-depth discussions on various items during this…
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Highlights from the EMA-industry ‘platform meeting’
The purpose of these “centralised platform” meetings is to promote awareness about the changes introduced in the centralised evaluation procedure. Initially these meetings are meant to focus on procedural aspects, and may at a later…
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Adaptive Licensing
A Brief Summary of the new fast-track European procedure by Simon Ruini, Director of PhD London The Adaptive Licensing Pilot Project was launched by the EMA on 19 March 2014. This summary addresses some frequently asked…
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Regulatory information – Companies now required to update, complete and improve quality of information on authorised medicines
From today, the European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation. This includes completing previously…
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EMA and FDA meet on new initiatives
Senior leadership from DG Health and Consumers (European Commission), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) discussed a number of key initiatives at a bilateral meeting which…
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Orphan Products Approvals in Europe
A total of 11 out of 81 medicines recommended for marketing authorisation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of…
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EMA publishes Q&A on Art. 31 Referrals
By Simon Ruini, London 23 Jan 2014 The Q&A guidance document on Article 31 Referrals addresses a number of questions which marketing authorisation holders (MAHs), may have on referral procedures resulting from the evaluation of…
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A reminder on biological applications
Biological similar medicinal products Biological medicinal products have a successful record in treating serious and chronic diseases. The recent expiry of data protection/ patents for the first original biotherapeutics has led to the development and authorisation…