Is the risk of GMP dis-harmonisation in the field of ATMPs (Advanced Therapy Medicinal Products) real?
- 12 мая 2017
- ATMP, CTA, GMP, IMP, MAH, PIC/S, высокотехнологичные лекарственные средства, лекарственные препараты для клинических исследований, НПП,
The PIC/S Committee, which comprises representatives of PIC/S’ 49 Participating Authorities as well as representatives from Partner Organisations such as EMA, EDQM and WHO, expressed its unanimous concern at the European Commission’s proposed stand-alone Advanced Therapy Medicinal Products (ATMP) GMP Guidelines, which will not only lower GMP standards for ATMP at the risk of patients