New regulations have come into force relating to the development of drugs for Children, and these regulations will impact on every single drug development programme currently ongoing. It is critical that you know about these regulations and how to adapt to them.
Every product must have agreed a Paediatric Investigational Plan (PIP) with the EMEA (via the PDCO – Paediatric Committee) before they register their product. In the future this will change to every product must be implementing a PIP before they can register their product.
The PIP describes the investigation that you propose to do in order to establish safety and efficacy in a paediatric population. You must put this plan together with the expectation of carrying it out. Every product must have one, it will not be acceptable to just say “children don’t get this disease” you will have to prove it.
The committee will not give a waver for any technology that can not prove that their therapy could benefit children. If there are enough Paediatric Patients to power a comparison study it will have to be undertaken.
If you would like to know more about these rules have a look at the this website.
We will be publishing more information on this in the near future.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a 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 using the contact form or email Damien at damien.bove@idaconsultants.com
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my 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.
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Wow! Thank you very much! I always wanted to write in my site something like that
Great point and very interesting food for thought. I’m not sure I have any clients I can replicate this with, but will bear in mind for the future. Regards
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