ASU Comparison of US and EU Regulatory Framework

Step 1:  Prepare a table to compare and contrast the requirements for a new drug application to  FDA and EU. You may do this collectively or individually.

Step 1:  Create a table in excel or word.  Across the top list the requirements for 

FDA – 21CFR211

Along the left side list the requirements for

EU – Annex 1

to an external site.

to an external site.

Step 2:  Place an “x” in the box where the 2 requirements are the same or similar.

Step 3:  Select another region to compare and contrast and add this to your table.  Other regions include ANVISA, PMDA, KFDA, TVA, SFDA, Health Canada, CoFEPRIS, SFDA, or any from this link

to an external site.

Create a separate table with these requirements.

Step 4:  Put an “*” in the box, of your table comparing US to EU, where the requirement for FDA and your other HA requirement is the same or similar.

Step 5:  Put a “+” in the box, of your table comparing US to EU, where the requirements for EU and your other HA requirements are the same or similar.

Compare US food regulation to European food regulations.  And then select another country and do the same.  Follow the instructions above.