title: [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].
abstract: At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.
authors.affiliation: Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland. Johanna.Kuhlmann-Gottke@pei.de.
authors.forename: Johanna
authors.initials: J
authors.lastname: Kuhlmann-Gottke
authors.affiliation: Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225, Langen, Deutschland.
authors.forename: Karin
authors.initials: K
authors.lastname: Duchow
mesh_terms: D000820:Animal Diseases / Q000628:therapy*; D000818:Animals; D001688:Biological Products / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000627:therapeutic use; D064987:Cell- and Tissue-Based Therapy / Q000379:methods* / Q000662:veterinary*; D005060:Europe; D005858:Germany; D006801:Humans; D033581:Stem Cell Transplantation / Q000379:methods* / Q000662:veterinary*; D035703:Therapies, Investigational / Q000379:methods* / Q000662:veterinary*; D014730:Veterinary Medicine / Q000379:methods*
chemical_list: D001688:Biological Products; D019496:Cancer Vaccines
keywords: Cell-based medicinal products; Regulatory requirements; Stem cells products; Tumour vaccines; Veterinary medicine