Module 5 Presentations

05/07/2024

Questions

41

References

Dir. 2001/20/EC (Clinical Trials)

• Guideline on similar biological medicinal products containing biotech derived proteins as active substances (EMEA/CHMP/BMWP/42832/2005) • Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (EMA/CHMP/BWP/247713/2012) • Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMA/CHMP/BMWP/42832/2005) • Notification on the clinical trial of medicinal products for human use. A joint publication of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute (10 Aug 2006) • Muazzam U, Key Requirements for the Evaluation/Compilation of the Quality Dossier . 2008

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Dir. 2003/94/EC (GMP)

Reg. 536/2014 (Clinical Trials)

CHMP/QWP/185401/2004 (NCE Quality) EMA/CHMP/QWP/545525/2017 (NCE Quality, Regulation update) CHMP/QWP/185401/2004 (Biologicals Quality) EMA/CHMP/BWP/534898/2008 rev. 1 (Biologicals Quality, Regulation update) SANCO/C/8/SF/cg/a.5.001(2011)332855 (NIMPS) CTAG Auxiliary Medicinal Products in Clinical Trials, Mar 2024 MHRA, Common issues identified during clinical trial applications . Accessed 28 Jun-2024 Auxiliary Medicinal Products in Clinical Trials , 28-Jun-2017 Draft Guideline on Quality, Non-clinical and clinical requirements for investigational ATMPs in Clinical Trials (Draft) (EMA/CAT/852602, 2019) EC Guideline 2010/C 82/01 (CT-1)

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