On 4 April 2017 EMA’s Committee for Medicinal Products for Human Use (CHMP) published the draft guideline (dated 23 March 2017).
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 2019-03-14