With the announcement of TMMDA dated April 28, 2022, the updated "Guideline on the Investigation of Bioavailability and Bioequivalence of Medicinal Products for Human Use", which regulates the procedures and principles of bioavailability and bioequivalence studies submitted during and after the registration phase of medicinal products for human use, has been published and entered into force.
The third paragraph of article 5 of the guide titled “Bioequivalence studies” will enter into force on 1 January 2023.
You can access the announcement from the link below:
https://lnkd.in/dNTPB9Mi