[Requirements for long-term follow-up on efficacy and safety of advanced therapy medicinal products. Risk management and traceability].
Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP regulation is the requirement for long-term follow-up on safety and efficacy of patients enrolled in clinical trials with ATMPs, which is beyond the routine requirements on pharmacovigilance. For gene therapy medicinal products, a guideline on long-term follow-up, which lays down the technical requirements, is available. A further key element of the ATMP regulation is the traceability of the starting materials used to manufacture the ATMP. A common European coding system is imperative to ensure the traceability of starting materials, especially across the borders of European Member States.
Klug
B
B
Paul-Ehrlich-Institut, Langen.
Reinhardt
J
J
Schröder
C
C
D001691:Biological Therapy / Q000009:adverse effects / Q000592:standards*; D017690:Cell Transplantation / Q000331:legislation & jurisprudence* / Q000592:standards*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D005500:Follow-Up Studies; D005818:Genetic Engineering / Q000331:legislation & jurisprudence* / Q000592:standards*; D015316:Genetic Therapy / Q000331:legislation & jurisprudence* / Q000592:standards*; D005858:Germany; D017408:Guidelines as Topic / Q000592:standards; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012308:Risk Management / Q000331:legislation & jurisprudence; D016896:Treatment Outcome