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Gene Therapy in Germany and in Europe : Regulatory Issues In the European
| Content Provider | Semantic Scholar |
|---|---|
| Author | Cichutek Kraemer |
| Copyright Year | 1998 |
| Abstract | In the European Union the marketing authorization for gene therapy products is obtained following the centralized procedure for marketing authorization via the European Agency for Evaluation of Medicinal Products (EMEA). For evaluation and review of clinical protocols there is no authority established at the level of the European Union. The different member states have settled on an ad hoc review process on different levels, i.e. national regulatory agencies, local or national ethics committees and others. The following paper gives an overview on the regulatory issues of gene therapy in Europe focusing mainly on the specific situation in Germany. The view of the regulatory authorities is compared with the perspective of a pharmaceutical company. Additionally key features of the regulations in the UK and France are briefly outlined. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://www.genetherapynet.com/download/GT-in-Germany.pdf |
| Language | English |
| Access Restriction | Open |
| Subject Keyword | Authorization Centralized computing Hoc (programming language) Pharmaceutical Preparations Pharmacy (field) Protocols documentation |
| Content Type | Text |
| Resource Type | Article |
