Ing. Helmut Schütz

EU – EMA

Guideline therapeutic equivalence for locally applied and locally acting products

On 4 April 2017 EMA’s Committee for Medicinal Products for Human Use (CHMP) published the draft guideline (dated 23 March 2017).

Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents (CPMP/EWP/239/95 Rev. 1)

This guideline defines the requirements that need to be fulfilled to waive clinical trials with clinical or pharmacodynamic endpoints in the demonstration of therapeutic equivalence for locally applied, locally acting gastrointestinal products. It also defines the in vivo bioequivalence studies and in vitro equivalence tests that are necessary..

End of consultation is the 30 September 2017.

document date 2017-04-04 | last update 2022-10-19