Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines

Regulatory NewsRegulatory News | 08 October 2021 |  By 

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling for greater harmonization of genetically modified organism (GMO) procedures for investigational medicinal products, saying the complex process has the potential to slow the initiation of clinical trials for advanced and cellular therapies.
In a perspective article in Cell & Gene Therapy Insights and a related press release, EFPIA said the current system is more restrictive than GMO requirements in the US and runs the risk that Europe will be perceived as being “less attractive to sponsors.” Since 2015 the United States has had a categorical exclusion for investigational advanced therapeutics and vaccines, the group said.
The discussion around GMO procedures in Europe is significant since the EU treats advanced therapies and medicinal products (ATMPs), including chimeric antigen receptor (CAR) T-cell therapies and vaccines, as GMOs. Earlier this year, EFPIA and other trade groups urged EU leaders to exempt ATMPs from the GMO legislation. (RELATED: ATMP trade organizations call for GMO exemption in EU, Regulatory Focus 27 May 2021)
In July 2020, the EU granted a temporary exemption from some provisions of the GMO requirements for potential COVID-19 treatments and vaccines, acknowledging the complexity and the potential for delays.
While a more widespread exemption continues to be the “best-case scenario,” EFPIA said that in the meantime EU member states need to ensure that they have a “practical and efficient system” in place that allows both the GMO assessment of the investigational medicinal product and the clinical trial authorization to be coordinated in time for the implementation of the Clinical Trials Regulation (CTR) in January 2022. The CTR, which has a one-year transition period, adds another layer to the regulatory process, EFPIA said.
The CTR is aimed at harmonizing the clinical trial application framework and creates a single electronic clinical trial application dossier that must be submitted to all EU member states involved in the trial. The single dossier is submitted through a portal called the Clinical Trials Information System (CTIS). However, the CTR has yet to address GMO documentation requirements for investigational medicinal products and the CTIS has no mechanism for submitting those documents. Specifically, the system lacks the functionality to receive certain GMO-related documents, such as the Environmental Risk Assessment and the EU Common Application Form.
“Implementation of a GMO exemption scheme before the end of the first year of the transition period for the CTR (the end of January 2023) is important to avoid new [clinical trial authorization] submissions for ATMPs under the CTR having to conduct the whole GMO assessment process in parallel. The same consideration also applies to vaccines,” EFPIA wrote in Cell & Gene Therapy Insights.
Cell & Gene Therapy Insights perspective


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