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.

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. 

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.

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.

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.

Chinese Parties to International Licensing Deals Should Consider How Terms Translate

Licensing deals are still relatively new in China compared to the United States and Europe. Tom Duley and Ruchun Ji explain why this means Chinese parties need to be careful about the history of terms and the choice of governing law and arbitration venue when negotiating contracts.

Points To Check When Selling Food Supplements Outside The U.S.

Major U.S. companies are expanding their vitamins, minerals, and botanicals businesses into Europe. Diane McEnroe, Anna-Shari Melin, and Nadja Schwarz explain what to consider in relation to formulation, labelling, and marketing language when targeting this market.

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