Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard
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MHRA Issues Statement of Policy Intent Regarding Early Access to Innovative Medical Devices
On 31 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a statement of policy intent relating to a service to provide early access to the Great Britain market for innovative medical devices (“Early Access Service”). Although
MHRA Announces Consultation Response on Reforms to GB Pre-Market Medical Device Regulation
On 22 July 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published the outcome of its most recent medical device-related consultation. The MHRA also announced its intention to consult further on the indefinite recognition of CE-marked medical devices
Quantum Computing and its Impact on the Life Science Industry
Quantum computing uses quantum mechanics principles to solve certain complex mathematical problems faster than classical computers. Whilst classical computers use binary “bits” to perform calculations, quantum computers use quantum bits (“qubits”). The value of a bit can only be zero
Non-Dilutive Financing: The U.S. Trend Catching on in Europe’s Life Sciences Sector
Raising capital to discover, develop, and commercialize new drugs has always been a regular feature for life sciences companies, and the current environment of tight equity markets and lower company valuations has caused significant strains. In response, many European life
China’s Draft Environmental Code: Access and Benefit-Sharing for Chinese Non-Human Biological Resources – What Life Sciences Companies Should Know
On April 29, 2025, China released a landmark draft of its first unified Environmental Code, now open for public consultation until June 13, 2025. The 2025 Draft Environmental Code (“Draft Code”) consolidates and elevates into a single legal instrument many
What Companies Should Know About the WHO Pandemic Agreement
Image Credit: World Health Organization
On 16 April 2025, Member States of the World Health Organization (WHO) concluded negotiations on a new international treaty: the Agreement on pandemic prevention, preparedness and response (“WHO Pandemic Agreement”). Set to be adopted at
EU Joint Procurement – An Overview
The joint procurement by the European Commission (“Commission”) and the Member States of COVID-19 vaccines and therapeutics presented a significant milestone in the EU’s management of the pandemic. In the aftermath of the pandemic, there have been repeated calls for
European Health Data Space Published
On March 5, 2025, the Regulation on the European Health Data Space (“EHDS”) was published in the Official Journal (see here). The text enters into force on March 25, 2025, however it only becomes applicable in a staggered manner
The Updated NHS Commercial Framework for New Medicines
On 29 January 2025, NHS England (“NHSE”) published an updated Commercial Framework for New Medicines (the “Commercial Framework”). The Commercial Framework, first published in 2021, sets out NHSE’s approach to commercial activity in relation to new branded medicines and is