Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Sven De Knophttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSven De Knop2024-07-02 10:20:232024-07-02 10:21:01EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Geoffrey W. Levinhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngGeoffrey W. Levin2024-06-26 10:49:382024-06-26 10:49:38Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors
Biotech and medtech startups based in the People’s Republic of China (P.R.C.) are flocking to Hong Kong to float. Meng Ding explains how a combination of listing reforms and an explosion of innovation in the Greater Bay Area have led to Hong Kong’s 18A process being popular for life sciences.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2024-05-29 09:04:212024-05-28 15:42:48Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
Sidley’s Chad Ehrenkranz and UK-based U.S. investor Chris Yoshida consider which AI-based healthcare applications are of most interest to private equity investors, and the way in which healthcare AI lies in a desirable spot between startups and government uses of AI.
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/05/GLS-Blog_Generic-imagery-12.png606833Maria Isabel Manleyhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaria Isabel Manley2024-04-11 10:32:352024-06-04 15:41:26New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2024-03-19 17:31:042024-03-20 11:00:24EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
September 24The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK
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EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
Sven De Knop
Brussels
sdeknop@sidley.com
Lei Li
Beijing, Shanghai
lei.li@sidley.com
Maryanne W. Kamau
Brussels
mkamau@sidley.com
Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors
Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.
Geoffrey W. Levin
New York
glevin@sidley.com
Torrey Cope
Washington, D.C.
tcope@sidley.com
Maria Isabel Manley
London
mmanley@sidley.com
Donielle McCutcheon
Chicago
dmccutcheon@sidley.com
Andrew W. Shoyer
Washington, D.C.
ashoyer@sidley.com
Michele Tagliaferri
Brussels
mtagliaferri@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
Hong Kong’s Biotech Listings Emerge From Two-Year Downturn With 18As Booming
Biotech and medtech startups based in the People’s Republic of China (P.R.C.) are flocking to Hong Kong to float. Meng Ding explains how a combination of listing reforms and an explosion of innovation in the Greater Bay Area have led to Hong Kong’s 18A process being popular for life sciences.
Meng Ding
Hong Kong
meng.ding@sidley.com
Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process.
Maria Isabel Manley
London
mmanley@sidley.com
George Herring
London
gherring@sidley.com
Private Equity Investors’ Attitudes Towards Healthcare AI Investment Opportunities
Sidley’s Chad Ehrenkranz and UK-based U.S. investor Chris Yoshida consider which AI-based healthcare applications are of most interest to private equity investors, and the way in which healthcare AI lies in a desirable spot between startups and government uses of AI.
Chad Ehrenkranz
New York, Miami
chad.ehrenkranz@gmail.com
New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
Maria Isabel Manley
London
mmanley@sidley.com
Dr. Alexandra Anna Theochari
Trainee Solicitor
atheochari@sidley.com
EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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