Clinical Trials on Advanced Therapy Investigational Medicinal Products in Spain (2004–2022): Experience and Challenges for the Future

Author:

Estévez Álamo Juan,Timón Marcos,Sánchez Afán de Rivera Isabel,Iriarte Torres Beatriz,Serrano Castro M. Antonia

Publisher

Springer International Publishing

Reference37 articles.

1. 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. Vols. OJ 2007 L 324: 121–137.

2. European Commission. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4: Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, 2017. [Online] 28 12 2022. https://ec.europa.eu/health/documents/eudralex/vol-4_en.

3. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Vols. OJ 2004 L 102, p. 48–58.

4. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC – Commission Declaration. Vols. OJ L 106, 17.4.2001, p. 1–39.

5. Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance). Vols. OJ L 125, 21.5.2009, p. 75–97.

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