The UK’s Medicines and Healthcare products Regulatory Agency plans on issuing guidance on co-developing medicines and IVDs in the near future.
Big changes are in the pipeline for how companion diagnostics are regulated in the EU following the entry into force of the new medical device regulations, according to Stephen Lee of the UK Medicines and Healthcare products Regulatory Agency’s Devices Division, who discussed companion diagnostics during a July 14 joint meeting in London sponsored by MHRA and the UK BioIndustry Association.
The new rules-based risk classification for IVDs means more work for notified bodies as 80 to 90 percent of devices will have to go through them. Reference laboratories and expert panels will be created with the goal of helping notified bodies develop more expertise, he said.
Lee highlighted the EU regulations’ inclusion of a definition and assessment route for a companion diagnostic — “a device which is essential for the safe and effective use of a corresponding medicinal product, to identify before and/or during treatment [for] patients who are most likely to benefit from the drug in question, or to identify patients at risk of a serious adverse event.”
According to his interpretation of the rules, following an analytical study, the clinical performance of a proposed companion diagnostic could be tested during Phase II/III trials.
The medicines regulator will give an opinion on the suitability of the test for use with the corresponding drug to feed into the notified body’s review, Lee said.
National medicines regulators and notified bodies will work together on conformity assessments with the goal of approving a medicine and its companion diagnostic around the same time, he said.