The above mentioned flow chart explains the identification process of eligibility criteria for ATMP processing.
We’ve started ATMP applications in early January 2019 in accordance with European regulations f.e AMG (German Arzneimittelgesetz), the European GCP-Guidelines (from 28.5.2016 EU-VO on clin. test.) furthmore to the European ATMP regulations.
For more specific information we refer to the DOWNLOAD section of our webpage whereas interested parties can obtain information about the latest ATMP REGULATIONS.
The scheme above describes the safety and efficacy concerns for ATMPs.
ATMPs provide new possibilities for restoring, correcting or modifying physiological functions, or making a medical diagnosis. At the same time, because of their novelty, complexity and technical specificity, they may cause new, risks to patients. The specific rules described in the guideline (check our DOCUMENT DOWNLOAD SECTION) should facilitate early detection of such risks and provide a framework for effective mitigation of their consequences to patients.