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 […]
The Medicines and Healthcare products Regulatory Agency (MHRA) is leading an action to reinforce the market surveillance of medical devices by Competent Authorities. The Joint Action on Market Surveillance of Medical Devices aims to improve the coordination of activities by all Member States of the European Union (EU). The system also seeks to ensure adequate […]
A public consultation has been launched by the European Commission (EC) to gain feedback on the Paediatric Regulation. Ten years after its implementation and to support the EC in drafting its second report, the consultation aims to assess the impact of the Regulation on public health and the pharmaceutical industry. Initial findings collected by the […]
Following our update in June on the start of an EU-wide review of guidelines for first-in-human clinical trials, the European Medicines Agency (EMA) is proposing a number of changes aimed at improving safety. The draft revised guideline was adopted by the EMA’s Committee for Medicinal Products for Human Use (CHMP) following a review which was […]
The International Conference on Harmonisation (ICH) has recommended a new topic for the development of a guideline to support the use of the Biopharmaceutics Classification Systems (BCS)-based biowaivers in respect of bioequivalence studies. The new guideline will BCS-based biowaivers and result in harmonisation of current regional guidelines whilst supporting the streamlining of global drug development. […]
The European Medicines Agency (EMA) has now given open access to clinical reports for new medicines for human use that have been authorised in the European Union (EU). The public, including researchers and academics, will now be able to access the clinical reports submitted to the EMA as part of a marketing authorisation application. The […]
The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new working group to boost medicine development for rare diseases. The new ‘cluster’ on rare diseases will facilitate the sharing of experiences and best practices on regulatory approach. It will also enable the exchange of information on […]
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