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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 (Text with EEA relevance) article 4 CELEX: 02007R1394-20190726 Clinical trials
1. The rules set out in Article 6(7) and Article 9(4) and (6) of Directive 2001/20/EC in respect of gene therapy and somatic cell therapy medicinal products shall apply to tissue engineered products. 2. The Commission shall, after consulting the Agency, draw up detailed guidelines on good clinical practice specific to advanced therapy medicinal products. |