EMA Announce Adoption Date for ICH E6 (R2)

On the 15th December, the European Medicines Agency (EMA) became the first of the regulatory authority to confirm an effective date for ICH E6 (R2). This date the guidelines will come into effect for the EMA is 14th June 2017.


As seen with ICH E6 (R1), the EMA have led the way, becoming the first to adopt.

For convenience, we have added the adopted guidance document to our resources page:

ICH E6 (R2) EMA Adopted Guidelines

So, after a long year of discussion and delays in 2016, 2017 is going to be the year we really start to see the major changes in the ICH guidance being implemented.

What does this mean for you?

While many companies are already in the process implementing the changes required, or thinking about implementation, we know from the extensive surveillance of the industry performed by TRI in 2016 that only 11% of industry have adopted the new processes and tools required in order to be compliant, and only 24% are in the process of developing and adopting new processes and tools.

That leaves 65% of the industry yet to get started.

TRI have developed an approach to fast-track companies running clinical trials who wish to accelerate their understanding and state of readiness for ICH E6 (R2). We take a simple and pragmatic approach to getting companies to a state of compliance quickly and cost effectively.

TRI have developed a simple approach to accelerated ICH E6 (R2) compliance

To find out more please feel free to contact us at info@tritrials.com and we will be happy to give you a no obligation introduction to our approach and the results we are getting with those customers we have already worked with.