Regulatory News

EMA Lays out Plans for Companion Diagnostic Guideline

The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines.

Specifically, EMA says its guideline will address the development of companion diagnostics for precision medicines in the clinical development and post-approval phases, and will include a glossary defining terms used in the guideline as well as in the IVDR.

Once adopted, EMA says the guideline will replace its existing reflection paper on the co-development of pharmacogenomics markers and assays released in 2010.

According to the agency, the decision to use a personalized medicine hinges on the use of companion diagnostics to determine whether a patient will benefit from a medicine, or alternatively whether the patient is at a higher risk for adverse reactions to the treatment.

 "It is very important to clarify how evidence to support the validation of a companion diagnostic can be generated during the development of a medicine," EMA says.

However, EMA is not directly involved in authorizing companion diagnostics, as they are treated as in vitro diagnostic medical devices in the EU and can be marketed after being CE marked.

But, the agency says the new EU in vitro diagnostic regulation (IVDR) "foresees cooperation between medicines regulators and EU notified bodies … in the evaluation of new companion diagnostics to obtain the CE label."

According to EMA, drug and diagnostic developers oftentimes begin work on their products independently, and come together "only superficially towards the end" of the development phase, which the agency says is not ideal.

EMA also says it hopes developing guidance in this area will lead to more "close knit development programmes."

EMA, Concept Paper