Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products

Author:

Salmikangas P.,Flory E.,Reinhardt J.,Hinz T.,Maciulaitis R.

Publisher

Springer Science and Business Media LLC

Subject

Public Health, Environmental and Occupational Health

Reference20 articles.

1. McNeil S (2007) Progress and opportunities for tissue-engineered skin. Nature 445:874–880

2. Getgood A, Brooks R, Fortier L, Rushton N (2009) Articular cartilage tissue engineering: today’s research, tomorrow’s practice? J Bone Joint Surg Br 91-B:565–576

3. Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004

4. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use

5. EMEA/CHMP (2006) Guideline on human cell-based medicinal products EMEA/CHMP/410869/2006

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