New EMEA guidelines launched
The European Medicines Agency (EMEA) has issued a practical guidance note for companies requesting scientific advice or protocol assistance from its experts:
The European Medicines Agency (EMEA) has issued a practical guidance note for companies requesting scientific advice or protocol assistance from its experts:
(www.emea.eu.int/pdfs/human/sciadvice/426001en.pdf).
The agency has also released a guideline on devising acceptable names for European Union-authorised medicines - (www.emea.eu.int/pdfs/human/regaffair/032898en.pdf), and a discussion paper on how it releases negative opinions or refusals for medicine marketing applications - (www.emea.eu.int/pdfs/human/euleg/31135505en.pdf)
FInally, EMEA has published a guideline on influenza vaccines prepared from viruses with the potential to cause a pandemic - (www.emea.eu.int/pdfs/human/vwp/26349906enfin.pdf).