Useful Links

Regulatory Authorities

FDA (Food & Drug Administration)

IMB (Irish Medicines Board)

International Conference on Harmonisation

Regulations

Code of Federal Regulations

Volume 4 of “The rules governing medicinal products in the European Union” GMP Guidelines

ICH Guidelines

International Organisation for Standardisation

Guidance

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Pharmacovigilence

The EU Pharmacovigilance System