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LATEST NEWS UPDATE
EudraGMP database now also con...Following the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) in January of this year, the EudraGMP dat... |
EU Commission publishes version 4.0 of Q&A documen...The EU Commission has published version 4.1 of its Q&A document on "Written Confirmation". The requirement for “written confirmation” from the competent authority of the exporting country to accompany each batch of API imported into the EU from third countries will come into effect on 01 J... |
FDA publishes new draft Guidance for Industry: SUP...The U.S. FDA has published a new draft Guidance for Industry: SUPAC - Manufacturing Equipment Addendum. The guidance document is being distributed for comments at this time. It combines and supersedes the following two Scale-up and Post-approval Changes (SUPAC) Guidances for industry: • SUPAC... |
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