Bioequivalence and Bioavailability Forum

Hi Osama,

good point!

❝ Are there any regulations,Guidlines regarding to how long is a BE study valid?

Not that I recall. I once suggested a “shelf-life” for BE-studies at a conference and the following discus­sion was, well, lively. Even members of EMA’s PKWP didn’t see any reason to reject and “old but good” study.
OK, but can a fifteen year old study realistically conform to current standards? Mine don’t.
Practically EMA “tagged” studies which were performed before February 2012 if ISR is missing. There are some ways out, which are described in the Q&A-document, Section 13.
Experiences here and there.

❝ I mean, if a study is conducted, say 2001, and was applied to registered at this time, could the manufacture apply with the same study on 2014 for another regulatory agency?

Sure. I know one company which at an amazing rate submits studies I have performed for them in the last century to Middle Eastern agencies… Must be fun to review them.

Dear wien-ui
As Helmut explained there are some risks that an old BE study does not meet current requirements. However, there is a different approach to get a marketing authorisation but to start a new application (=new product). I guess the product is already marketed and hence safety and efficacy is given as shown by the pharmacovigilance system. Therefore it should be possible to plan a MRP (=already marketed product). This procedure should not fail since the already marketed product is well established and it is in the interest of the RMS to promote this product otherwise this would mean that the RMS authorised a product in former times that could present possible risk to public health. In consequence this would mean that all products will Need new BE studies which is absurd. Once you got your marketet authorisation you can not lose it because BE requirement changed and you started a new procedure. So it is the dilemma of the RMS to promote you product and if you have a strong RMS this will work for you. We made this experience with several products and only needed to give a reasonable Explanation why missing ISR does not matter.
I hope this helps
Kind regards
Dr_Dan