1 The administration of the product to the clinical trial subject requires an approval under special regulations for gene therapy only.
Figure 1: Consultation process with environmental competent authorities with respect to environmental risk assessment for medicinal products for human use during assessment of marketing authorisation applications
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2. Iglesias-López C, Agustí A, Obach M, Vallano A. Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States.Front Pharmacol . 2019;10:921. doi:10.3389/fphar.2019.00921
3. Commission Directive 2009/120/EC of 14 September 2009 Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community Code Relating to Medicinal Products for Human Use as Regards Advanced Therapy Medicinal Products (Text with EEA Relevance) . Vol OJ L.; 2009. Accessed June 11, 2020. http://data.europa.eu/eli/dir/2009/120/oj/eng
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5. Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast)Text with EEA relevance. :23.
6. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the Deliberate Release into the Environment of Genetically Modified Organisms and Repealing Council Directive 90/220/EEC - Commission Declaration . Vol OJ L.; 2001. Accessed June 11, 2020. http://data.europa.eu/eli/dir/2001/18/oj/eng
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8. ARM, EFPIA, EBE, EuropaBio. Position paper: Possible solutions to improve the European regulatory procedures for clinical trials with Advanced Therapy Medicinal Products consisting of or containing Genetically Modified Organisms. Published September 27, 2017. Accessed May 28, 2020. https://www.ebe-biopharma.eu/wp-content/uploads/2017/09/Position_paper_ARM_EFPIA_EBE_EuropaBio_27Sept17_longversion.pdf
9. Ten Ham RMT, Hövels AM, Klungel OH, Leufkens HGM, Broekmans AW, Hoekman J. Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection. Trends Pharmacol Sci . 2020;41(2):67-71. doi:10.1016/j.tips.2019.11.007
10. 2002/813/EC: Council Decision of 3 October 2002 Establishing, Pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the Summary Notification Information Format for Notifications Concerning the Deliberate Release into the Environment of Genetically Modified Organisms for Purposes Other than for Placing on the Market . Vol 280.; 2002. Accessed June 16, 2020. http://data.europa.eu/eli/dec/2002/813/oj/eng
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12. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC Text with EEA Relevance . Vol 158.; 2014. Accessed June 16, 2020. http://data.europa.eu/eli/reg/2014/536/oj/eng
13. Medicinal products for human use containing or consisting of GMOs: interplay between the EU legislation on medicinal products and GMOs - frequently asked questions. Accessed June 16, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/gmcells_qa_en.pdf
14. Common application form for viral vectors contained in investigational medicinal products for human use. Accessed June 11, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/vvs_caf_en.pdf
15. Common application form for investigational medicinal products for human use that contain or consist of AAV vectors. Accessed June 11, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_caf_en.pdf
16. Common Application form for clinical research with human cells genetically modified by means of retro/lentiviral vectors. Accessed June 11, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/gmcells_caf_en.pdf
17. Good Practice on the assessment of GMO related aspects in the context of clinical trials with AAV clinical vectors. Accessed June 11, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/aavs_gp_en.pdf
18. Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified by means of retro/lentiviral vectors. Accessed June 16, 2020. https://ec.europa.eu/health/sites/health/files/files/advtherapies/docs/gmcells_gp_en.pdf
19. European Medicines Agency. Guideline on Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products_en.pdf. Published online 2008:14.
20. European Medicines Agency. EMA pre-authorisation guidance. Published September 17, 2018. Accessed June 11, 2020. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pre-authorisation-guidance
21. European Medicines Agency. EMA standard-operating-procedure-consultation-environmental-competent-authorities-genetically-modified_en.pdf. Published December 2019. Accessed June 11, 2020. https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-consultation-environmental-competent-authorities-genetically-modified_en.pdf
22. European Commission. Press release: Coronavirus: Commission unveils EU vaccines strategy. Published June 17, 2020. Accessed June 17, 2020. https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1103