歐洲藥品局（EMA）于2017年3月公布了"證明用于局部并在胃腸道局部起作用的產(chǎn)品治療等效性的等效性研究指導(dǎo)原則（草案）"，提出了對(duì)這類(lèi)等效性研究的一般要求，詳細(xì)地介紹了對(duì)作用于口腔和（或）咽喉、胃、腸道以及直腸等胃腸道不同部位的藥物等效性研究的要求，重點(diǎn)介紹了臨床試驗(yàn)替代方法-體外等效性試驗(yàn)和藥動(dòng)學(xué)生物等效性研究。介紹該指導(dǎo)原則主要內(nèi)容，期望對(duì)我國(guó)這類(lèi)仿制藥和改劑型藥療效一致性評(píng)價(jià)思路和方法有啟發(fā)。

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.