EMEA Publishes Concept Paper on Guidance for Clinical Investigations for Lipid Disorders and Hypertension.
Current CHMP recommendations for the clinical development of lipid lowering and blood pressure (BP) lowering agents accept the possibility of drug registration for the so called biological indications. This means that the basis for the demonstration of the efficacy of these drugs can be their effect on biological markers (LDL-cholesterol and BP respectively). Not being the intention of the CHMP to modify this policy, more clarity is needed to explicitly state where these principles would not be applicable and further data on the effect of these medicinal products on morbidity and mortality would be requested before a marketing authorisation is given.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Turn your Business Into an Investor Magnet
How to Write a Business Plan – Free E-Course
Get the secrets that turns your project into an investment magnet, 100% of our clients raise the finance they need to take their projects to the next stage, we will share these secrets with you. – Sign up for Free
Grow your Expertise for Free
As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.
