The European Medicines Agency (EMA) has published several scientific guidelines to help applicants prepare marketing-authorisation applications for human medicines and veterinary medicines. These guidelines also serve as supporting tools for the scientific assessment of the regulatory dossiers by the Biosafety Council, the SBB and their external experts.
Particularly in relation to the environmental risk assessment of GMO medicinal products the following guidelines (non-exhaustive list) can be of interest (links to the EMA website):
- Consideration document: General principles to address virus and vector shedding - 01/06/2009
- Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products – 01/11/2008
- Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs) – 01/07/2007
- Guideline on environmental risk assessment of medicinal products for human use - 01/12/2006 - Currently under revision
- Guidance on environmental risk assessment for veterinary medicinal products consisting of or containing genetically modified organisms (GMOs) as or in products - 10/03/2006
The following guidelines, related to the quality, non-clinical and clinical aspects, may also be of interest (links to the EMA website):
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Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products - 13/07/2018
- Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - 03/05/2012
- Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines – 10/08/2010
- Guideline on live recombinant vector vaccines for veterinary use - 08/06/2005
- Guideline on development and manufacture of lentiviral vectors – 26/05/2005
The Biosafety and Biotechnology Unit (SBB) also issued scientific publications that are relevant to the biosafety assessment of GMO (investigational) medicinal products, in particular:
- A Baldo, E Galanis, F Tangy, P Herman (2016) Biosafety Considerations for Attenuated Measles Virus Vectors Used in Virotherapy and Vaccination. Human Vaccines & Immunotherapeutics. Published on line.
- A Leunda, A Baldo, M Goossens, K Huygen, P Herman, M Romano (2014) Novel GMO-Based Vaccines against Tuberculosis: State of the Art and Biosafety Considerations. Vaccines 2(2):463-499
- F Lim, H Khalique, M Ventosa, A Baldo (2013) Biosafety of vectors derived from Herpes Simplex Virus Type 1. Current Gene Therapy 13(6): 478-491
- M Goossens, K Pauwels, N Willemarck, D Breyer (2013) Environmental risk assessement of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Current Gene Therapy 13(6): 413-420
- A Baldo, E van den Akker, H Bergmans, F Lim, K Pauwels (2013) General Considerations on the Biosafety of Virus-derived Vectors Used in Gene Therapy and Vaccination. Current Gene Therapy 13(6): 385-394
- C Verheust, M Goossens, K Pauwels, D Breyer (2012) Biosafety aspects of Modified Vaccinia Virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Vaccine 30(16):2623-2632
- K Pauwels, R Gijsbers, J Toelen, A Schambach, K Willard-Gallo, C Verheust, Z Debyser, P Herman (2009) State-of-the-art lentiviral vectors for research use: Risk assessment and biosafety recommendations. Current Gene Therapy 9(6):459-474