NB (notified bodies) lobbying of MCA (UK Medicines Control Agency) on combination product reviews pays off
This article was originally published in Clinica
Executive Summary
Complaints from notified bodies (NBs) in the UK that the Medicines Control Agency takes too long in its review of drug/device combination products have been acknowledged by the agency. The NBs had said that what they saw as the MCA's difficulty in processing straightforward assessments was upsetting their clients' launch strategies. The MCA last week told Clinica that it will address this reputation for being slow in assessing products that combine device and medicinal elements.