GMP for Advanced Therapy Medicinal Products (ATMPs) (Part II) and hospital exemption (HE)
- 14 February 2018
- advanced therapy medicinal product, aseptic manufacturing, ATMP, biosafety, clinical trials authorisation, CTA, data integrity, decentralized manufacturing, GMO, GMP, HE, hospital exemption, IMP, investigational medicinal product, MAH, manufacturer, manufacturing, manufacturing platform, marketing authorisation, marketing authorisation holder, operating theatre, process validation, risk assessment, sponsor, unmet medical needs,
On 22 November 2017, the European Commission (EC) has adopted and published Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, one of the initiatives of the Action Plan for ATMPs launched in October 2017 to foster the development of ATMPs. Advanced Therapy Medicinal Products (ATMPs) manufacturers should comply with these Guidelines