Industry Regulatory / Guidance References

QA Validation Engineer supportEU GMP Related Directives

Directive 2001/83The EU Community Code for Human Medicinal Products
Directive2001/20The EU Clinical Trials Directive
Directive 2003/94The EU GMP Directive

Other EU Legislation/Guidance

EMA Human MedicinesEU Information for Human Medicines
EudralexEU Legislation for Medicinal Products
Eudralex Pharma SectionEU Pharmaceuticals Information
Eudralex Volume 1 – Legislation HumanEU Legislation for Human Medicinal Products
Eudralex Volume 3 – Guidelines HumanEU Scientific Guidelines for Human Medicinal Products
Eudralex Volume 4 – GMP Human and VeterinaryEU GMP Guidelines for Human and Veterinary Medicinal Products
Good Distribution PracticeGuideline on Good Distribution Practice
Mutual Recognition Agreements (MRAs)Information on Mutual Recognition Agreements between EU and Non-EU Countries
 The Orange Guide Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015

MHRA Legislation/Guidance

UK Medicines Act 1968UK Legislation on Medicines
Licensing of MedicinesInformation on Licensing of Medicines in the UK
UK GMPInformation on UK GMP
UK Guidance NotesUK Guidance Notes for Medicines
GMP Q&AMHRA Frequently Asked Questions on GMP
UK S2012/1916The Human Medicines Regulations 2012

US Legislation/Guidance

CFRsUS Legislation on Food, Drugs and Cosmetics
FDA Investigations Operation ManualGuidance on FDA Inspections – General
FDA Inspection GuidesGuidance on FDA Inspections – Specific Topics
FDA CBER Guidance/Guidelines/Points to ConsiderFDA Guidances and Regulatory Information for Biologics
FDA CDER GuidancesFDA Guidances and Regulatory Information for Drug Products
FDA Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing Current GMPUS Guidance on Requirements for Aseptically Manufactured Drug and Biological Products

e-Cigarette Legislation/Guidance

PMTA GuidanceFDA Pre-Market Tobacco Application (FDA)
FDA Deeming RuleFDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
CTPControlled Tobacco Products (USA)
MHRA Tobacco DirectiveTobacco & Related Products (UK)