The Alliance for Regenerative Medicine (ARM) has called for Europe to streamline approval of clinical trials of advanced therapy medicinal products (ATMP). ARM wants regulatory agencies to cut review timelines and harmonize their approaches to support the development of cell and gene therapies.
Europe has played a central role in the emergence of ATMPs. The European Medicines Agency (EMA) approved a gene therapy long before its regulatory peers and was the first authority to adopt specific rules covering the development and approval of the nascent class of medicines. However, a survey of ATMP developers run by ARM suggests the European Union may be losing ground as a destination for clinical trials.
The survey found clinical development activity in Europe is flatlining, with sponsors starting 2% more trials in 2018 than in 2014. In contrast, the number of clinical trials initiated in North America and Asia rose by 36% and 28%, respectively, over the same period.
There is evidence that the trend cannot be explained by the relative sizes of the ATMP sectors in each region. The number of ATMP developers in Europe is around half that of North America. Yet, Europe is home to around one-third as many clinical trials as North America.
ARM thinks the regulatory environment may be contributing to the relative lack of clinical trials in the EU. Respondents to the survey cited speed of approval and the quality of review and expertise at health authorities as two of the top three criteria for selecting the location of a clinical trial site.
The outgoing clinical trial directive permits regulators to take longer to adjudicate on filings to study ATMPs than other types of medicine. ATMP review times remain longer in the incoming clinical trial rules, although the survey suggests that is far from the biggest problem facing the industry. The data show review times vary across Europe, with authorities in Belgium and the United Kingdom typically signing off on studies within 60 days while their counterparts in France and Germany take six to 12 months.
Some of the long delays stem from national procedures for research involving genetically modified organisms (GMO). National agricultural or environmental agencies typically handle GMO reviews in the EU. ARM wants to see a consistent approach to GMO review taken across Europe and is calling for national authorities to add the capabilities they need to quickly process applications.
“It is important to ensure that ATMP clinical trials are approved in the shortest possible timeframes,”
“To effect this, national competent authorities must allocate sufficient resources and ensure an adequate level of expertise for the review of clinical trial applications for ATMPs.”