“It is important to ensure that ATMP clinical trials are approved in the shortest possible time frames” said the Alliance for Regenerative Medicine (ARM).
ARM wants regulatory authorities to harmonise their approaches to support advanced therapy medicinal products (ATMPs), such as cell and gene therapies, as these medicines may offer ground-breaking new opportunities for the treatment of disease and injury.
The European Medicines Agency was the first authority to adopt specific regulations for the development and approval of ATMPs. However, a recent survey has shown that they may be falling behind as a destination for clinical trials. Between 2014-2018, North America had a 36% rise in the number of clinical trials started, compared to 2% for the European Union (EU).
ARM believe regulatory factors such as speed of approval, quality of review and expertise of the health authorities are defining criteria for sponsors choosing the location of their trials. Additionally, the outgoing clinical trial directive permits regulators to take longer to review ATMP trial filings, relative to other medicines.
Data from the survey showed that there is great variation in the review times across different countries in the EU. For example, the United Kingdom (UK) and Belgium generally sign off studies within 60 days, whereas France and Germany can take 6-12 months. This variation has been caused by differences in national procedures for research involving genetically modified organisms (GMO), which are normally the responsibility of agricultural and environmental agencies.
ARM wants to see a harmonised and consistent approach to GMO reviews across the EU, thereby increasing harmonisation of clinical trial review times for ATMPs. To facilitate this, they recommend that the national regulatory authorities allocate sufficient resources to ensure adequate levels of expertise, which will bring the EU back to the forefront of ATMP development.
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