Gene Therapy
Information:
- Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99)
- German Registry for Somatic Gene Transfer Studies, DeReG
Information and comments on the safety of gene transfer studies:
- Comment by the Paul-Ehrlich-Institut on an open letter from the British Gene Therapy Advisory Committee (UK GTAC)
- Letter of Information issued by the Paul-Ehrlich-Institut and the German Medical Association on the hold of clinical gene transfer studies in Germany following a case of leukaemia in France.
- Summary information from the Paul-Ehrlich-Institut on the hold of clincal gene transfer studies folowing a case of leukaemia in France.
- Report from the "Gene Therapy Expert Group (GTEG) at the European Medicines Agency (EMEA) on cases of leukaemia after gene therapy
- Information from the Paul-Ehrlich-Institut: Third case of tumour development after SCID gene therapy in France.
Articles from the Journal Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz
These articles are in english or have english summaries.
| Titel | Datum | |
|---|---|---|
|
Erfahrungsbericht aus dem Ausschuss für neuartige Therapien (CAT) : Fallstricke auf dem Weg vom Konzept zur medizinischen Anwendung neuartiger Therapien |
13.07.2011 | pdf 256 KB |
|
Environmental risk assessment for medicinal products containing genetically modified organisms |
04.02.2010 | pdf 371 KB |
|
Einrichtung eines zentralen Registers klinischer Gentransferstudien in Deutschland |
21.06.2004 | pdf 246 KB |
|
Retroviral Vectors |
31.10.2001 | pdf 207 KB |
|
Regulatorische Aspekte der Anwendung von Gentransfer-Arzneimitteln in der Humanmedizin |
31.10.2001 | pdf 149 KB |
|
GMP-gerechte Herstellung von Gentransfer-Arzneimitteln |
31.10.2001 | pdf 96 KB |
|
Gentherapie: Gut‘ Ding will Weile haben |
31.10.2001 | pdf 65 KB |
