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Julia Gillert

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In Pharmaceuticals & Biotech

Guest Feature: India Pharma Focus – 4 Key Industry Developments to Track

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The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch: 1. Patent (Amendment) Rules 2024: Beware shorter…

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In Healthcare Services

Further EU Sanctions Tighten on Russia and Belarus – Impacting the Healthcare Sector

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Alongside its allies, the EU has implemented a vast volume of sanctions on Russia and Belarus following Russia’s invasion of Ukraine in February 2022. The EU sanctions against both Russia and Belarus are at the core of the EU’s response to Russia’s military aggression and aim to diminish Russian resources and curb Russia’s capacity to continue the war. On 24 June 2024, the EU introduced its awaited 14th sanctions package on Russia and not long…

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In Digital Health

Machine Learning Medical Devices – FDA, UK MHRA and Health Canada Join Forces (Again) in Promoting Transparency

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In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are now developing a proposed regulatory framework for modifications to Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a…

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In Healthcare Services

Psychedelics – will reform happen fast enough?

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The conversation on psychedelics around the world continues to evolve, with more and more emerging clinical data highlighting their potential to treat mental health disorders. Last year’s developments – see our previous blog post here – led us to anticipate an upcoming change but yet the legal landscape remains unchanged. In the UK, the independent Parliamentary Office of Science and Technology (POST), which is one of the first independent bodies of its kind in the…

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In Pharmaceuticals & Biotech

Has the European Parliament Missed the Chance to Boost Orphan Drug Development?

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The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…

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In Medical Devices

UK MHRA’s International Recognition for Medical Devices

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The UK’s MHRA has published a statement of policy intent for recognition of international regulators’ approvals of medical devices in Great Britain (GB). If your organisation’s medical device is authorised in any of Australia, Canada, the EU, or USA (together, Comparable Regulator Countries or CRCs), you may be able to leverage this to gain fast-tracked access to the GB market. This means that manufacturers may be able to side-step the full UK authorisation process for…

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In Digital Health

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

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 30 April 2024 set out its strategic approach to artificial intelligence (AI). In particular, the MHRA welcomed the publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and has taken significant steps in the past 12 months to adopt its recommendations in the work they do based on five key strategic principles. These principles encompass safety, security and robustness; appropriate…

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In Pharmaceuticals & Biotech

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

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As the pharmaceutical industry adjusts to the further changes the Windsor Framework will bring, there are important changes ahead for parallel import licensing across the UK. The transition from Parallel Distribution Notices (PDNs) to Parallel Import Licences (PLPIs) has introduced new requirements that will impact parallel distributors in Great Britain and Northern Ireland. In Great Britain, PDNs have already been replaced by PLPIs, allowing products to be marketed exclusively within the region. However, with the…

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In Digital Health

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

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How does the EU AI Act impact upon medicines R&D? The answer is not much at all. This position stems from an exemption for scientific R&D in the AI Act, as explained by a recent statement from the European Federation of Pharmaceutical Industries and Associations (EFPIA). This will be welcome news for the pharmaceutical industry, but questions remain for the medical device industry, where the position is far murkier at the research and development stages.…

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In Digital Health

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

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Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…

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