EMA publish an updated reflection paper on API Starting Materials

In July this year, an updated version of the "Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances" was published by EMA. The difference from the previous version is that the last paragraph of  "Explanatory note 2" has been revised to clarify the requirements for the API process description in case the intermediates have an approved CEP and/or an ASMF which is already included in a finished product authorized in the EU.

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500175228.pdf