Healthcare & Life Sciences Blog -

Extended Producer Responsibility for Pharmaceutical and Cosmetics Companies: the Recast Urban Wastewater Treatment Directive

by Rachel MacLeod and Bibi Badcock-Scruton

Digital Health

MHRA launches AI Airlock to address challenges for regulating medical devices that use Artificial Intelligence

by Elina Angeloudi, Julia Gillert and Jaspreet Takhar

Pharmaceuticals & Biotech

UK Guidance introduces new requirements on parallel distributors in Great Britain and Northern Ireland

by Elina Angeloudi, Julia Gillert and Jaspreet Takhar

Digital Health

The EU AI Act and medicines R&D: EFPIA brings clarity, but open questions for devices

by Julia Gillert and Jaspreet Takhar

Medical Devices

The European Commission launches an investigation into Chinese public procurement of medical devices

by Bregt Natens, Arnoud Willems and Magda Tovar

Digital Health April 4, 2024

Clinical Trials Agreements – How Much Flexibility is there for Sponsors Across the Globe?

Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the…

Digital Health March 20, 2024

EU AI Act Approved by the EP – Update and Insight Into Other AI Industry Specific Developments

EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The…

Medical Devices February 21, 2024

New Emirates Drug Corporation Soon to be Operational Replacing MOHAP as Federal Regulator of all Medical Products

To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will…

EU Pharmaceutical Package

In EU Pharmaceutical Package

A New Dawn for the EU Pharma Regulatory Regime? The Commission’s Proposal to Revise the EU Pharmaceutical Legislation is Finally Published

April 26, 2023 by Els Janssens, Magda Tovar and Julia Gillert 5 Mins Read

Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous…

In EU Pharmaceutical Package

EU Pharma Package: How Significant are the Proposals for Orphan Medicines?

May 16, 2023 by Els Janssens, Magda Tovar and Julia Gillert 6 Mins Read

On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue…

In EU Pharmaceutical Package

Hungarian Pricing and Reimbursement Reforms Aiming to Remove Hurdles to Late Market Access of Innovative Pharmaceuticals

May 26, 2023 by Dr. Helga Bíró M.Jur. and Máté Laczkó 3 Mins Read

In brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is…

In EU Pharmaceutical Package

The EU Pharmaceutical Package From a National Perspective: Member States’ First Reactions

May 30, 2023 by Els Janssens, Julie Yeni, Dr. Martin Altschwager LL.M., Dr. Frank Pflueger and Magda Tovar 6 Mins Read

The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the…

In EU Pharmaceutical Package

The Future is Green: Eco Measures are Embedded into the EU Reform Proposals

June 13, 2023 by Julia Gillert, Els Janssens and Magda Tovar 2 Mins Read

As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals…

In EU Pharmaceutical Package

Supply Chain Protection: What do the EU Reform Proposals Look Like and do They go Far Enough?

June 13, 2023 by Julia Gillert, Els Janssens and Magda Tovar 3 Mins Read

As already well noted on this blog, on 26 April 2023 the European Commission published a set of…