Bioequivalence and Bioavailability Forum

Dear Preet,

you are right - MCC removed the "Expiry date" of five years in the current version.

❝ 'The bioavailability/bioequivalence study(ies) should comply.

❝ with the requirements of current standards as determined by.

❝ Council'.

❝

❝ Could you please provide your insight on "current standards as determined

❝ by council".

❝ What are these current standards (wrt Expiry date)? Where I will get these

❝ standards?

Since no "Expiry date" is mentioned, I would guess MCC will not enforce this former requirement any more.

❝ Also, what provoked them (MCC) to change the criteria? Any expert

❝ comments!

Since I am not an expert in RSA's regulations I can only speculate. An "Expiry date" is not required in any BE guideline worldwide. So maybe it's a step towards harmonization - forced by industry's pressure?