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The EMA has issued the following Scientific guideline ( CPMP/EWP/239/95 Rev. 1) which builds on the guidance of the clinical requirements for locally applied locally acting products containing known constituents:
Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract .
This is a revision to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents.
If you wish to comment on this document, please get in touch with me by 24th September. Thank you
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