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The regulation of advanced therapy medicinal products

The regulation of advanced therapy medicinal products The development of medicine, biomicrobiology and biotechnology has led to the emergence of a cutting-edge category of medicinal products that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools, both in terms of legislation and regulatory guidance, to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislature regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance. However, the regulation of genetically modified organisms (GMOs) which are used as starting materials for ATMPs remains national and therefore differs from one Member State to another. Such differences have led to a complex regulatory landscape for ATMPs. The regulation of tissues and cells...

Coronavirus (COVID-19) news & analysis—May & June 2020 [Archived]

Coronavirus (COVID-19) news & analysis—May & June 2020 [Archived] ARCHIVED: This Practice Note has been archived and is not maintained. This table contains an archive of news and analysis on coronavirus (COVID-19) and coronavirus developments that has been published within various Lexis+® UK Practice Areas in May and June 2020. 29–30 June 2020 Date News Analysis Brief description of News Analysis 30 June 2020 INSOL Europe/ÀÏ˾»úÎçÒ¹¸£Àû® coronavirus (COVID-19) Tracker of Insolvency Reforms—Cayman Islands Restructuring & Insolvency analysis: We look at the reforms to the insolvency law of Cayman Islands prompted by the coronavirus pandemic. Written by Nicholas Fox, partner, Mourant Ozannes, Cayman Islands, member of INSOL Europe. 30 June 2020 (Coronavirus (COVID-19))—rent recovery and protection in Scotland—what commercial landlords can do Property Disputes analysis: Landlords’ ability to recover outstanding rents has been impacted by the coronavirus and associated legislation, guidance and practice directions issued, but some options can still be explored. The options landlords in the UK have differ depending on which part of the UK they are...

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Where can I find the Brexit legislation concerning product certification/conformity (eg CE marking) and the extent to which products will be recognised in the event of a no deal Brexit?

Where can I find the Brexit legislation concerning product certification/conformity (eg CE marking) and the extent to which products will be recognised in the event of a no deal Brexit? We would like to refer you to the Brexit legislation tracker — Brexit SI database, which collates details of draft and made SIs laid before Parliament in preparation for Brexit. For further updates and background reading on the latest primary and secondary Brexit legislation, please see Practice Note: Brexit legislation tracker. The following draft regulations listed in the database contain modifications or references to the EU legislation (or related domestic legislation) listed in Annex A of the government no deal notice on trade in regulated goods: • Draft Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019(laid under the draft Affirmative procedure) • Draft Ecodesign for Energy-Related Products and Energy Information (Amendment) (EU Exit) Regulations 2019(laid under the draft Affirmative procedure) As stated in the government notice, there may be more specific examples which...

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Government ploughing ahead with new legislation to make ‘the UK the best place in the world to invest in agri-food research and innovation’

Environment analysis: Tom Gillett, associate at Steptoe & Johnson, discusses the Genetic Technology (Precision Breeding) Bill, which was introduced in Parliament on 25 May 2022.

Life Sciences weekly highlights—14 October 2021

This week's edition of Life Sciences weekly highlights includes analysis of how AI regulators can work through the difficulties of future-proofing once the Artificial Intelligence Regulation comes into force—using the life sciences sector as a framework, news that the EFPIA has called for harmonisation relating to the ways in which genetically modified organism (GMO) clinical trials are conducted ahead of the implementation of Regulation (EU) 536/2014 (the EU Clinical Trials Regulation), details of the CMA’s case closure summary following its investigation into suspected breaches of competition law relating to nitrofurantoin capsule supply, and the latest coronavirus (COVID-19) developments.