Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive

Author:

Maciulaitis Romaldas,D'Apote Lucia,Buchanan Andrew,Pioppo Laura,Schneider Christian K

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology,Genetics,Molecular Biology,Molecular Medicine

Reference18 articles.

1. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products;European Commission (2009);Official Journal of the European Union,2009

2. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004;European Parliament and Council;Official Journal of the European Union,2007

3. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe;Schneider;Nat Rev Drug Discov,2008

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