Regulatory


The European Medicines Agency spent eight years developing the CTIS.


directive’s guidelines. Now, the rules are intended to apply consistently across all member states, but that is not happening.


“In my opinion, the regulation itself is clear and


doesn’t cause any problems,” says Maciołek. The problems, she adds, start when it comes to the implementation of CTR at national level. “Unfortunately, we don’t see harmonisation here and local requirements for Part II dossiers vary from country to country. Large pharmaceutical companies and global CROs restructured their regulatory departments and now have one team, usually global, preparing Part I dossiers, but they have different teams, usually local, preparing country-specific Part II packages, and different teams of CTIS administrators to support technical aspects of the EU portal.” Roussanov is also somewhat disappointed, because what was supposed to be one set of rules for the entire EU, has been complicated by some member states wanting their own specificities that require companies to complete Part I and Part II dossiers on a country-by- country basis. Some of these differences arise from interpretations of the General Data Protection Regulation (GDPR). For instance, a hospital is usually the processor of personal data, and that is accepted by most states, but not Germany and the Netherlands, where hospitals are data controllers. This is where the feel of the road under the wheels of the bus starts to change abruptly. “The EU is marketed as a single market, but in practice, it is very different,” says Roussanov. “Countries have small quirks that are significant because they build up the complexity of running a trial in the EU. US companies wanted the new regime to be


10


like the FDA, where you make one application and can then run trials across a whole jurisdiction, but in the EU, there are differences between countries.” Now, some companies prioritise other jurisdictions over the EU, even though the aim of the CTR was to maintain or increase the number of studies being done in the EU. “So, it is not a clear win, though whether it is a failure is open to discussion,” he adds. “Maybe we expected more than we could achieve. Maybe we were delusional.” Despite the teething problems with CTR, however, there is a sense that it would not take too much to iron out the rough edges and get the system and the rules around it working as intended. If innovative companies stop coming to Europe because it is not cost-effective to run trials in the bloc, then it would be a big blow for the industry, so there is good reason to get everyone working towards the same goal.


The magic ingredients are cooperation and collaboration, which are not always easy in a region as large as the EU or in an industry that is heavily regulated and demands the highest standards of risk management. In one sense, however, the journey towards CTR has proven that it is possible for disparate stakeholders to work together. “One big positive is that this is one of few cases where industry, the EMA and all stakeholders are on the same page,” says Roussanov. “If that cooperation continues, it would be a very good sign.” Good intentions are the bedrock of meaningful change. Now comes the hard work of making sure the tarmac is smooth and seamless between all member states.●


Clinical Trials Insight / www.worldpharmaceuticals.net


martinbertrand.fr/Shutterstock.com


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41