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Sep 2017

The Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on the importance of applying human factors to the design of medical devices, including those used in drug-device combination products. The guidance is aimed at manufacturers and developers of all device classes, as well as notified bodies responsible for assuring the quality of those […]

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Sep 2017

Marketing Authorisation Holders (MAHs) of centrally approved products are reminded that, from 1 September 2017, the use of the European Medicines Agency’s new form to accompany the submission of data in connection with post-authorisation measures (PAMs) is mandatory. The new form is intended to simplify the submission process for PAMs for MAHs and automatically informs […]

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Jul 2017

In this latest update on Brexit from PharmaLex, we report on the release of the latest, specific Q&As in relation to pharmaceutical regulation and provide our comments. Both the European Medicines Agency (EMA) alongside the European Council (EC) and Co-ordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) have now issued Q&A documents […]

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May 2017

We have previously reported on how the European Medicines Agency (EMA) has issued statements about the possible implications of Brexit. CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures – Human) has now also issued a similar statement aimed specifically at Marketing Authorisation Holders (MAHs). We note with interest that the guidance for switching the […]

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May 2017

Europe’s leading Biopartnering and Investment conference, BioTrinity 2017, is on in London this week. Not only is it a great opportunity for life science companies across the world to meet under one roof, it is also an opportunity to find new partnerships to support your product development plans. Attending the conference on behalf of PharmaLex this […]

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Feb 2017

On the 5th May 2017, the European Commission is hosting a multi-stakeholder workshop to develop a Q&A on the use of biosimilar medicines aimed at healthcare professionals. The session follows two previous workshops, where information has been gathered and subsequently shared to enhance patient understanding and trust of the use of biosimilars throughout Europe. The […]

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Jan 2017

The European Medicines Agency (EMA) is planning to launch a pilot project in February 2017 to assess the viability and value of customised scientific advice for the development of biosimilars. The new approach will provide a more in-depth assessment of the data concerning development to date, focussing on quality, analytics and function. The EMA hopes […]

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