title: Regulatory environment for allergen-specific immunotherapy.
abstract: Products for specific immunotherapy (SIT) are medicinal products according to the European Regulations. To obtain a marketing authorization (MA) within the European Community, the quality, safety and efficacy have to be proven. During the development phase of a medicinal product, applicants have the opportunity to apply for scientific advice by national competent authorities or the European Medicines Agency (EMA) to compile a suitable development plan for the examination of quality and performance of nonclinical and clinical trials. Moreover, a paediatric investigation plan has to be submitted to the Paediatric Committee of the EMA and has to be approved before submission of an application for MA. Several regulatory procedures exist for obtaining a MA in the European Community. The national procedure leads only to marketability in one country whereas the Mutual Recognition, the Decentralized and Centralized Procedures (CP) are intended for MA in several or all member states of the European Union. The CP is mandatory for certain medicinal products, for example for drug substances derived by biotechnological processes such as recombinant allergens. Named Patient Products for SIT are a specialty because they are manufactured on the basis of an individual prescription and marketed without a MA.
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Division of Allergology, Langen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Kaul
authors.forename: S
authors.initials: S
authors.lastname: May
authors.forename: D
authors.initials: D
authors.lastname: Lüttkopf
authors.forename: Stefan
authors.initials: S
authors.lastname: Vieths
mesh_terms: D000485:Allergens / Q000627:therapeutic use*; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards; D003888:Desensitization, Immunologic / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D006967:Hypersensitivity / Q000628:therapy*; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*
chemical_list: D000485:Allergens; D004364:Pharmaceutical Preparations