DrugQualityandSafetyComparisonofEMEAandFDARules.ppt

Drug Quality and Safety: Comparison of EMEA and FDA Rules;What we will discuss;How is EU regulation different?;Isn’t the EMEA like the FDA? Not quite.;In the EU, coordination is a challenge;EU regulators have some tools that are not universally available in the U.S. In the EU: ;FDA has some advantages,especially in times of crisis;How are the U.S. and EU similar:;EU 101;EU 101: legal instruments;Glossary;  EU Pharma: Key Players;  EU Pharma: Key Players;  EU Pharma: Key Players;  EU Pharma: Key Players;  EU Pharma: Key Players;  Pharma: Key Players;Recent regulatory changes;Thalidomide?Directive 65/65, which launched European Community harmonization of regulation of medicinal products ;Clinical Trials Directive—2001/20 Community Code on Medicinal Products--2001/83: the Human Use Directive codifying 65/65, 78/318, 75/319, 89/342, 89/341, 89/381, 92/25, 92/26, 92/27, 92/28, etc. July 2001: Start of Review Process that? legislation published April 30, 2004;2003/63: New Annex 1 to Directive 2001/83 ICH Common Technical Document is implemented additional requirements for biological medicinal products “clarifying” coverage of gene therapy and somatic cell therapy Commission Regulations on Variations, (EC) No 1084/2003 of 3 June 2003 and Commission Regulation (EC) No 1085/2003 of 3 June 2003;“EMEA Regulation” (EC) 726/2004: authorisation and supervision of medicinal products for human and veterinary use and on the European Medicines Agency (EMEA) (replacing Regulation (EC) 2309/93)  Directive 2004/27/EC amending the Community code on medicinal products for human use (Directive 2001/83/EC)  Directive 2004/24/EC on traditional herbal medicinal products (also amending Directive 2001/83/EC) Directive 2004/28/EC amending the Community code on medicinal products for veterinary use (Directive 2001/82/EC);Timeframe for implementing laws published April 30, 2004;  Decentralized Procedure vs Centralized : Scope; Comparis