International Regulations
Canada
European Commission
- CE Marking
- EU Legislation Governing Pharmaceuticals
- General Data Protection Regulation (GDPR) – April 26, 2016 (effective date May 25, 2018)
- Pharmaceutical Legislation Medicinal Products for Human Use – Directives and Regulations
European Medicines Agency
- Data Transparency and Clinical Trial Reports to the EMA: A Compliance Guide
- Regulatory and Procedural Guidance Index
- External Guidance on the Implementation of EMA Policy on the Publication of Clinical Data for Medicinal Products for Human Use