Latest Articles

The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017. Although the EMA recognises on its Brexit webpage, that the future relationship between the UK and the EU is…
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational New Drug Application or the applicant that submits a New Drug Application or Biologics License Application; or in…
Today, 25 May 2017, two new Regulations come into force in the European Union: the Medical Device Regulation (MDR) which replaces two EU Directives on general medical devices and active implantable medical devices; and the In Vitro Diagnostic Medical Devices Regulation (IVD MDR) which replaces the EU Directive on IVD medical devices. Now begins a transition period of three years under the MDR and five years under the IVD MDR. The Regulations provide…
In this briefing we cover recent regulatory developments for mobile health (mHealth) in the European Union and set out a summary of the current framework. mHealth is a sub-segment of electronic health (eHealth) and covers medical and public health practice supported by mobile devices. It especially includes the use of mobile devices for health and well-being services and information purposes as well as mobile health applications. eHealth is part of the EU’s digital
The National Institute for Health and Care Excellence (NICE) produces guidance in a number of forms including technology appraisals. Technology appraisals are recommendations on the use of medicines and treatments within NHS England. The recommendations are based on a review of clinical and economic evidence. NHS England is legally obliged to fund medicines recommended by NICE’s technology appraisals. NICE and NHS England recently consulted publicly on changes to technology appraisals and highly…
In the European Union (EU), inspections of medicines manufacturing sites are carried out by national competent authorities from EU Member States. Each year, EU competent authorities and the US Food and Drug Administration inspect many manufacturing sites in the EU, US and elsewhere in the world, to ensure compliance with Good Manufacturing Practice (GMP). EU and US regulators have agreed to recognise inspections of manufacturing sites for medicines conducted in their respective territories. The agreement…
NHS England has published new guidelines on managing conflicts of interest. The guidance will come into force on 1 June 2017. It will be applicable to Clinical Commissioning Groups, NHS Trusts and NHS Foundation Trusts, and NHS England. The guidance covers common situations which can give rise to risk of conflicts of interest including gifts, hospitality and providing expertise outside employment, by: introducing consistent principles and rules for managing conflicts of interest; providing simple advice…
On February 2, 2017, the Government published a White Paper on its plan for exiting and achieving a new partnership with the EU. The White Paper expands upon Prime Minister Theresa May’s speech on January 17, 2017. We have previously written about the speech and earlier developments (The UK government’s Brexit plan and its implications for Life Sciences). See the full article here.…
Last week the US Food and Drug Administration (“FDA”) provided guidance on the Nonproprietary Naming of Biological Products. Each biologic, whether originator, related product or subsequent entry (biosimilar) will now be given a non-proprietary name comprised of a core name and a meaningless four-letter suffix. This is an important divergence from the practice in Canada and the European Union where a suffix is not required. It also differs from the practice for the naming…
On January 17, 2017, Prime Minister Theresa May delivered her much anticipated speech on the UK Government’s plan for exiting the EU. Continued membership of the EU’s single market and full membership of the customs union have both been explicitly ruled out. The plan for achieving a new partnership between the UK and the EU sets out 12 negotiating priorities including the UK: being the best place for science and innovation having control of its…