New EU Clinical Trial Regulations Coming. Are You Ready?

In March of 2016, regulators within the European Union (EU) have approved a new clinical trial initiative designed to quicken the approval process for promising new drugs that address medical needs that are otherwise currently unmet. This initiative will go into effect in the EU in May 2016. The European Medicines Agency (EMA) calls this new initiative PRIME—in reference to the priority medicines to which it will apply. It is similar in intent to the FDA “Breakthrough” designation, designed to speed approval of innovative drugs for serious diseases.

The EMA expects to receive approximately 100 applications for PRIME each year. They expect most of these from treatments for rare cancers and Alzheimer’s disease—as well as new classes of antibiotics designed to combat rising antimicrobial resistance.

Once accepted into PRIME, an experimental drug goes into clinical trials under the observation of an EMA-appointed expert who will provide support and guidance on development and strategy. With this guidance, EMA hopes to help companies with priority medicines in trial generate the data they need to gain approval.

It is important to note that the EU Clinical Trials Regulation differs in a number of key areas from both FDA Regulations and ICH Guidelines—as well as regulatory requirements in China, India, and Japan. In order to remain in compliance, we must not only understand the current regulatory situation in relation to clinical trials in the European Union, but the purpose of the new Clinical Trial Regulation and why it has replaced the existing directive. Understanding the impact the new regulation has is vital to all manufacturers running clinical trials under the new requirements.

Technical Training Opportunities

That Center for Professional Innovation and Education (CfPIE) offers innovative courses led by industry-active course instructors that focus specifically on developing an understanding of—and achieving compliance with—the new PRIME regulations, such as:

Understanding & Implementing the New EU Clinical Trial Regulation

European Regulatory Procedures - Comprehensive Overview of EMA and National Requirements

European Quality Submission Requirements

European Union Regulatory Issues – New Product Development

Filing Variations in the European Union

As the global leader in technical Life Sciences training, CfPIE offers training and certification programs that improve skills, maintain regulatory compliance, and enhance career opportunities.


Tags: 2016 , EU , Regulation