1. Strategic Plan for regulatory science and research 2012-2016;US Food and Drug Administration,2012
2. Human cells, tissues, and cellular and tissue-based products, 21CFR1271;US Food and Drug Administration,2012
3. 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 the Council of the European Union;Off J Eur Union,2007
4. Quality and safety assurance for drug products or medicinal devices with processed (homogeneous) human-derived cells or tissue;Pharmaceutical and Food Safety Bureau,2008
5. Quality and safety assurance for drug products or medicinal devices with processed (autologus) human-derived cells or tissue;Pharmaceutical and Food Safety Bureau,2008