Table 2 Relevant guidelines and regulations in developing MSC-based medicines for treating myocardial infarction

General

•European Medicines Agency Regulation (EC) No 1394/2007, Advanced Therapy Medicinal Products (amends Directive 2001/83/EC, 6 November 2001, O.J. L 311 and Regulation (EC) 726/2004, 31 March 2004, O.J. L 136). Official Journal of the European Union L 324. 13 November 2007

•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

•Guideline on human cell-based medicinal products (EMEA7CHMP7410869/2006)

Preclinical

•Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (ICH Topic M3 (R2))

•Note for guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals (CPMP/ICH/302/95)

•Safety pharmacology studies for human pharmaceuticals (ICH Topic S7 A)

•European Medicines Agency: 2004/9/EC—On the inspection and verification of good laboratory practice (GLP).

•European Medicines Agency: 2004/10/EC—On the harmonization of laws, regulations, and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.

Manufacturing

•Commission Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use

•European Medicines Agency: Directive 2003/94/EC—Laying down the principles and guidelines of good manufacturing practice with respect to medicinal products for human use and investigational medicinal products for human use.

Clinical testing

•European Medicines Agency: Directive 2005/28/EC—On the wholesale distribution of medicinal products for human use.

•European Medicines Agency: 2001/20/EC—On the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.