24 June 2026Publication
EU Pharmaceutical Package: Reform takeaways
Discover the essentials of the EU Pharma Package reform: key changes in protection, market access, supply, IP, advertising, digitalisation and policy.
Life Sciences companies are operating in a rapidly changing and increasingly demanding regulatory environment. Innovation, safety and value for money are major challenges. Well devised strategies add significant value. Breach of regulatory laws and codes attracts criminal and civil sanctions.
We have put specialist regulatory expertise at the heart of our Life Sciences sector group, building a flexible, integrated team based locally in major markets to respond to our clients’ needs at any stage of the product life cycle. Our European team is complemented by expert capability in the Middle East and China.
Our international regulatory and market access team works closely with our corporate, commercial and IP teams on:
- R&D contracts
- Clinical trials
- Manufacturing agreements
- Product classification
- Market access and CE marking
- Pricing & reimbursement
- Supply chain & distribution
- Advertising & promotional activities
- IP/Patents (life cycle strategies)
- Data and regulatory exclusivity
- Regulatory enforcement and
- Sanctions/compliance (criminal)
- Industry codes of conduct/self regulation
- Transparency – data and relationships with healthcare professionals
- Administrative/public law
- Public/private partnerships with healthcare institutions
- Product recall and liability
- Business development & partnerships
Our experience
Distribution of Cosmetic Products
Advising a pharmaceutical company in connection with the legal risks surrounding the distribution of certain cosmetic products under a disputed mark in China.
Clinical Development Strategy
Advising a top 10 global pharmaceutical company on EU data exclusivity issues arising from the proposed clinical development strategy in relation to a vaccine, involving the UK, Germany, Italy, Netherlands and France.
Nano-Physical Healthcare Products
Providing strategic advice to a global leader in nano-physical healthcare products in connection with the classification of its product in the UK (when classified differently in other European countries).
Key contacts
If you have any questions, contact a member of the Healthcare and Life Sciences Regulation team for assistance:
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China issues new regulatory data protection measures
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15 January 2026 Publication
10 Guiding Principles of Good AI practice
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18 December 2025 Publication
EU regulatory shifts for HLS in 2026
2026 will see several important legislative reforms and new initiatives that are expected to shape the sector’s operations and strategic priorities.
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18 December 2025 Publication
Damages from Medical Devices: Protection for Users
The new Directive (EU) 2024/2853 strengthens injured parties’ protection and redefines liability, burden of proof, and evidence rules in the supply chain.