Bioequivalence and Bioavailability Forum

Dear all,

although the ICH’s website states that M13A is in Step 5 (Implementation), this is not exactly correct. The guideline is in Step 4 (Final) and its implementation will take some time and differ between regions. There is no deadline and no obligation for an agency to implement it at all.

As an example the status of M10 Bioanalytical Method Validation and Study Sample Analysis (Step 4 on 24 May 2022) as of today:
$$\small{\begin{array}{llcll}
\phantom{000000}\textsf{Ageny} & \phantom{00000}\textsf{Region} & \textsf{Step} & \phantom{0000000}\textsf{Status}& \phantom{000000i}\Delta_\text{t}\\\hline
\textbf{ANVISA} & \text{Brazil} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) & \text{Implementation process} & \phantom{0000000}-\\
\textbf{COFEPRIS} & \text{Mexico} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) &\text{Not yet implemented} & \phantom{0000000}-\\
\textbf{EC} & \text{Europe} & \color{Green}5 &\text{21 January 2023} & \text{8 months, 29 days}\\
\textbf{EDA} & \text{Egypt} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) &\text{Implementation process} & \phantom{0000000}-\\
\textbf{FDA} & \text{United States} & \color{Green}5 &\text{7 November 2022} & \text{6 months, 15 days}\\
\textbf{HSA} & \text{Singapore} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) & \text{Implementation process} & \phantom{0000000}-\\
\textbf{HC} & \text{Canada} & \color{Green}5 & \text{20 January 2023} & \text{8 months, 28 days}\\
\textbf{MFDS} & \text{Republic of Korea} & \color{Green}5 &\text{26 October 2023} & \text{1 year, 6 months, 3 days}\\
\textbf{MHLW/PMDA} & \text{Japan} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) & \text{Not yet implemented} & \phantom{0000000}-\\
\textbf{MHRA} & \text{UK} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) & \text{Implementation process} & \phantom{0000000}-\\
\textbf{NMPA} & \text{China} & \color{Green}5 & \text{29 July 2023} & \text{1 year, 3 months, 3 days}\\
\textbf{SFDA} & \text{Saudi Arabia} & (\color{Red}4\color{Black}\to \color{Green}5\color{Black}) & \text{Not yet implemented} & \phantom{0000000}-\\
\textbf{Swissmedic} & \text{Switzerland} & \color{Green}5 & \text{25 May 2022} & \text{1 month, 1 day}\\
\textbf{TFFA} & \text{Chinese Taipei} & \color{Green}5 & \text{30 May 2023} & \text{1 year, 1 month, 5 days}\\
\end{array}}$$ In seven of the 14 regions the guideline is implemented, in four the implementation process is ongoing, and in three it has not even started – after more than two years. It might even be that Mexico, Japan, and Saudia Arabia decided against implementation…

If you have nothing better to do, check the status of M9 Biopharmaceutics Classification System-based Biowaivers (Step 4 on 20 November 2019).