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 […]
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 […]
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 […]
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 […]
As you will be aware, Article 50 was triggered on the 29th March 2017. Following this, negotiations will be commencing on the UK’s withdrawal from the EU. Although at this stage, it is unclear what the UK’s future relationship or co-operation will be with the EU regulatory system for medicinal products, we believe it would […]
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 […]
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 […]
The European Medicines Agency (EMA) has published a report on the impact of conditional marketing authorisations (CMAs). From 2006 until June 2016, a total of 30 CMAs were granted. The report highlights the positive impact that CMAs have had on providing access to new medicines for patients with unmet medical needs. CMAs can speed up […]
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 […]
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Tissue Authority (HTA) have signed an agreement which hopes to promote further collaboration between the two bodies. The strengthened partnership will cover the work carried out by both organisations in the UK, helping to ensure their approach to licensing and inspection is fair and […]
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For companies in the global pharmaceutical, medical devices and healthcare industries that require expert advice in regulatory affairs and pharmacovigilance, PharmaLex UK is a leading consultancy with a wealth of technical and practical experience and a reputation for innovative thinking. Our team of consultants use their collective and individual expertise to provide a flexible and approachable service that can be tailored to the needs of the client. Our aim is to consistently deliver successful outcomes and exceed expectations.