Advanced therapy medicinal products (ATMPs) include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue engineered products.
ATMP vigilance involves collecting, assessing, and preventing adverse events or any other medicine-related complications.
Reporting system in Germany
The reporting system allows for the systematic collection of severe adverse events associated with the use of ATMPs. Targeted measures for improving the safety of ATMPs are created using the data that is collected.
Marketing authorisation holders / pharmaceutical companies
Section 63i, paragraph 2 of the German Medicinal Products Act (Arzneimittelgesetz, AMG) details the marketing authorisation holders’ obligation to report. Under this obligation, every suspected severe adverse event must be reported to the competent authority within 15 days. The existence of a causal link and the severity of the reported reaction are assessed during the initial and follow-up reports.
Treating physician or transfusion specialist
If there is suspicion of an adverse event (severe or non-severe) associated with an ATMP, the pharmaceutical company should be informed by the treating physician. In the case of suspicion of a severe adverse event, the competent higher federal authority must also be informed within 15 days.