EMA
EMA PIP Reference numbers
Historically (and still referenced in many older documents and systems like EudraCT), the final EMA decision on a Paediatric Investigation Plan (PIP) was commonly identified by a short “P reference number” in the format P/xxx/yyyy…
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, so stop calling them so.
Individualised mRNA cancer immunotherapies do not meet the definition of vaccines, therefore the very sexy terminology of ‘cancer vaccines’ is inappropriate. MHRA’s clarifies own definitions (https://assets.publishing.service.gov.uk/media/6799ef4d9a6dc0352ab34225/Individualised_mRNA_cancer_immunotherapies_0.6.5.pdf). More appropriately, MHRA states that such products are individualised…
EMA Work Program for 2013
by, Simon Ruini 13 March 2013 The European Medicines Agency (EMA) has just released the work program for 2013. The executive director Guido Rasi stated that the Agency will pursue the following priority areas, in…