Smaller pharma companies warned of upcoming EU rule changes

Published: 22-Apr-2014
Regulatory

They come into effect on 15 June 2014


A bulletin designed to advise small and medium-sized companies within the European Union (EU) pharma sector has warned that a European Medicines Agency (EMA) guideline on process validation for finished products will come into effect on 15 June.

Published by EMA, the bulletin advises that the new guideline stipulates what process validation data should be submitted in regulatory submissions for finished dosage forms regarding medicines and active substances.

The bulletin also warns that a guideline on the use of porcine trypsin to make human biologics will come into effect on 1 September.

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