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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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Where medical devices used during the surgical procedures for application, implantation or administration of the advanced therapy medicinal product may have an impact on the efficacy or safety of the advanced therapy product, information on these devices shall be provided.
Specific expertise required to carry out the application, implantation, administration or follow-up activities shall be defined. Where necessary, the training plan of health care professionals on the use, application, implantation or administration procedures of these products shall be provided.
Human pharmacokinetic studies shall include the following aspects:
shedding studies to address the excretion of the gene therapy medicinal products;
biodistribution studies;
pharmacokinetic studies of the medicinal product and the gene expression moieties (e.g. expressed proteins or genomic signatures).
Human pharmacodynamic studies shall address the expression and function of the nucleic acid sequence following administration of the gene therapy medicinal product.
Safety studies shall address the following aspects:
emergence of replication competent vector;
emergence of new strains;
reassortment of existing genomic sequences;
neoplastic proliferation due to insertional mutagenicity.
For somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s), the pharmacokinetic profile (in particular distribution, duration and amount of expression) of those molecules shall be addressed, if feasible.
The biodistribution, persistence and long-term engraftment of the somatic cell therapy medicinal product components shall be addressed during the clinical development.
Safety studies shall address the following aspects:
distribution and engrafting following administration;
ectopic engraftment;
oncogenic transformation and cell/tissue lineage fidelity.
Where conventional pharmacokinetic studies are not relevant for tissue engineered products, the biodistribution, persistence and degradation of the tissue engineered product components shall be addressed during the clinical development.
Pharmacodynamic studies shall be designed and tailored to the specificities of tissue engineered products. The evidence for the ‘ proof of concept ’ and the kinetics of the product to obtain the intended regeneration, repairing or replacement shall be provided. Suitable pharmacodynamic markers, related to the intended function(s) and structure shall be taken into account.
Section 5.3.3 shall apply.] ]
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