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