On 21 May 2024, the European Medicines Agency (“EMA”) published a revised version of the Questions & Answers for applicants, Marketing Authorisation Holders of medicinal products and notified bodies with respect to the...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. It does not purport to provide...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular, to COVID-19, Russia’s war of aggression on against Ukraine, and cyber threats. ...more
On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more
The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more
The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking...more
LATEST KEY DEVELOPMENTS Competition & State Aid • Portugal is first Member State to officially deliver Recovery and Resilience Plan to European Commission • EU Single Resolution Board responds to European...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • European Commission issues Comfort letter on Cooperation at a Matchmaking Event – Towards COVID19 vaccines upscale production • European Commission publishes...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • Commissioner McGuinness addresses EU’s bank crisis management and deposit insurance framework, including COVID-19 crisis and State aid concerns • EU approves...more
LATEST KEY DEVELOPMENTS Competition & State Aid • European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic • EU approves new...more
LATEST KEY DEVELOPMENTS - Competition & State Aid • EU approves new and amended Member State measures to support the economy • Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more
The European Medicines Agency (“EMA”) and the EU network of Health Technology Assessment (“HTA”) bodies are jointly reviewing a proposed framework for patient preference studies. The intention of the proposed framework is to...more
On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more
The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. ...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation....more
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which...more
The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more