Introduction to EMA guideline on therapeutic equivalence studies of generic and reformulated products that are locally applied, locally acting in gastrointestinal tract / 药物评价研究

ABSTRACT

EMA announced 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 (Draft) in March 2017,and proposed the general requirements for this equivalence study,introduced the requirements of equivalence studies for drugs acting different parts of the gastrointestinal tract,such as the mouth and/or throat,stomach,intestine and rectum,in detail,which focus on alternative methods of clinical trials-in vitro equivalence tests and PK bioequivalence studies.The guideline is introduced and it is expected to enlighten the trains of thought and methods for efficacy consistency evaluation of such generic and reformulated products in China.