GMP News - APIs and Excipients

The EU Commission has recently published an extended Question and Answer Document on APIs importation into the EU and the "Written Confirmation". In addition, an up-to-date version of the "Written Confirmation" form has been released. Read more here about the changes made in both documents.

The British regulatory authority MHRA has published a new questions-and-answers document concerning the new rules on the import of active ingredients laid down in the Directive 2011/62/EU on the prevention of the entry of falsified medicinal products. Read more here.

The European Commission has published a Version 2.0 of the Q&A document "Importation of Active Substances for Medicinal Products for human use" on 26 October. Version 1.0 was published on 10 July 2013. Please read more here.

Local Chinese authorities are currently investigating against a few renowned API manufacturers who are accused of having used waste oil from restaurants for the production of their antibiotics. China's largest API manufacturers are among the accused manufacturers. Read more.

The new regulation of the Chinese State Food and Drug Administration defines a strengthened supervision of the manufacture of pharmaceutical excipients. Read here who will be affected by these new provisions.

The EDQM has recently published a document intended as a guide for the renewal or revision of a certificate of suitability. The EDQM hopes that this will reduce the time needed for the procedure and limit requests for additional information from CEP holders. Read more about this very helpful document here.

For some time now, the FDA has been strengthening its inspection activities at API facilities not only in the Far East but also in Europe. The analysis of the 8 Warning Letters which have already been issued for fiscal year 2012 confirms this trend. Read more here about what FDA investigators mostly have to object to in European facilities.