Understanding EU Clinical Trials

Pharma is big business, and with every new product that goes into development there is a long-term strategy to get that product into the marketplace. Before it can do so however, there are a few different processes that is has to work through successfully. Clinical trials are always an important part of safeguarding a pharma product before it can reach market, and with the right connections a new product can find the correct approach to undertake clinical trials and find a route into the marketplace in both the UK and the EU.

Back in 2014 the Clinical Trial Regulation was adopted by EU member states. It represented a pretty big shift in the way that clinical, trials would henceforth be conducted within the EU. There was good reason for this change in approach, as up to that point there had been no harmonisation between the clinical trials that were taking place in different European Union countries. The new regulations were aimed at ensuring that all clinical trials throughout the EU would follow the same rules of assessment and supervision. These measures would then be enforced by the EMA (the European Medicines Agency) through a brand-new system – CTIS (Clinical Trials Information System).

Oversight should always be a priority in any system involving pharma. When a new product comes to market, it should only be able to do so under the proviso that it has passed stringent safety tests and passed clinical trials. Without this safety net and the knowledge of what a product can do to a person, it could be ineffective at what it claims to do at best, or cause injury, illness or even fatalities at worst.

As well as setting out a consistent set of rules on how clinical trials should be run and assessed in the EU, the regulation also aimed to make all information relating to clinical trials available to the general public. For any product going through the process of clinical trials, all authorisation information, the conduct of the clinical trials, and all results, would be fed into a system for transparency and ease of access by the public.

Overall, this has led to a much higher level of consistency and efficiency of clinical trial programmes throughout the entire EU. In turn, this helps to increase levels of funding for research and helped pharma companies reach new targets and become much more innovative in concepts and potential products coming to market. It also ensures there is little wasted time, as there is less chance of the same clinical trials being conducted in different parts of Europe, as all of the information is readily available.

The function of a company with the logistical presence and know-how to get products to market is an essential one for many pharma companies. There are many potential pitfalls in play when dealing with new pharma products, and it is important that all protocol and EU regulation are adhered to if you are aiming to get your product in the EU marketplace. The Clinical Trial Regulation was an EU adoption that made a lot of sense, and it has certainly made for a more effective regulation of the safety of the pharma sector, with clear guidelines and assessment of clinical trials ensuring the highest of quality in terms of product safety before a product gets anywhere near the general public.

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