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Medicine development from lab to patient

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Paul Clift
Member
Posts: 467
Medicine development from lab to patient
Posted on: March 5 2019, 08:45 am

The European Medicines Agency (EMA) have just published a very informative and accessible guide to the development process of new medicines from the laboratory to reaching the patient:

https://www.ema.europa.eu/en/documents/other/laboratory-patient-journey-centrally-authorised-medicine_en.pdf

The EMA was based here in UK, at Canary Wharf in London, for 25 years and thanks to Brexit has now moved to Amsterdam. This is the first document I've seen from their new address.
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Ben Cromarty
Member
Posts: 451
Re: Medicine development from lab to patient
Reply #1 on: March 12 2019, 11:12 am

hi, Paul...

...thanks for this...useful and interesting.

I note that patients can be involved in the "Scientific Advice" bit...but rather proudly, the "did you know" says "In 2017, one in five scientific advice procedures involved patients and the SAWP members considered that in almost every case (93%) patients provided added value to the scientific advice. In more than one in four cases, the scientific advice recommended that the development plan be modified to reflect patient advice.". I would like to see a much higher figure! Why not EVERY case, if only for the purposes of transparency?

...similarly for Evaluation of Medicines: "In 2017, patients and healthcare professionals were involved in the
assessment of about one in four new medicines (excluding generics)."
...this now lumps patients with healthcare professionals, so we don't know the real number...but again, it could be higher!

...but it's a reassuringly thorough process!

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