The European Union (EU) has taken steps to streamline clinical trials regulations in an effort to restore the EU’s competitive edge in clinical research—and promote development of new medicines and treatments.
Revised regulations that govern the EU’s clinical trials were published in the Official Journal of the European Union in late May. As the EU noted in a recent statement, the previous system known as the 2001 Clinical Trials Directive had been subject to a great deal of criticism among researchers, patients, and industry representatives for being too inconsistent and costly.
“Taken together, these restrictions have contributed to a significant decline in the number of clinical trials in the EU–a reduction of about 25% in the last few years,” according to the statement.
In particular, the EU has been alarmed about the migration of the pharmaceutical industry and clinical trials to places like North America and South Asia, and wanted to take steps to reverse that trend, explained Mark Barnes, a partner with global law firm Ropes & Gray, LLP, in an interview. In addition to advising a range of clients about clinical trials, Barnes co-chairs the Multi-Regional Clinical Trials Center at Harvard, which studies the regulatory and ethical aspects of international clinical trials.
The new regulations seek to cut red tape and restore patient-focused research by simplifying several procedures, making it easier to conduct multinational clinical trials in more than one EU member state.
In the past, applications were submitted to the individual national offices of the Ministries of Health and in the EU member states, Barnes said. To establish a common submission mechanism, the EU plans to develop a central web-based portal for all applications, “which will be part of an overall information technology architecture to speed review and approval of clinical trial applications within the EU,” he said.
“Harmonizing the rules and introducing the single portal for applications is a huge step forward, which will make cross-border trials much easier to carry out,” Glenis Willmott, a member of the European Parliament and the rapporteur on the regulation, told Nature.com in an article published June 4. “This is especially vital for research into rare diseases, such as childhood cancers.”
The process for how the portal will be developed is not yet concrete, however, Barnes added. It isn’t scheduled to go into operation for at least another year.