Pharmaceutical company and non-profit regulatory environments: Understanding
to work together

International Regulatory Guidance & Collaboration Project

• Comparative guide to the regulatory environments affecting collaboration between pharmaceutical companies and patient organisations across 26 countries, alongside the core European Union framework.
• Explains how charity governance, pharmaceutical industry codes, funding rules, transparency requirements and organisational responsibilities shape collaborative activities.Provides country-specific guidance on independence, agreements, payments, communications, privacy and participation in research, regulatory review and access processes.
• Each country section gives an overview of key regulatory frameworks that pharmaceutical companies and non-profit organisation work to.
• Includes practical checklists for both parties to assess proposed collaborations, clarify responsibilities, manage conflicts of interest and support proportionate administration.
• Brings together an index of laws, regulations and related frameworks with consolidated references, supporting informed collaboration that protects organisational independence and advances patient benefit.