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
https://www.fda.gov/drugs/types-applications/new-drug-application-ndaLinks to an external site.
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation#Steps%20involved%20in%20obtaining%20an%20EU%20marketing%20authorisationLinks 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
https://www.who.int/medicines/areas/quality_safety/regulation_legislation/ListMRAWebsites.pdfLinks 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.
EU
Eudralex Volume 4
Scope
FDA
21 CFR 211
General Provisions
Scope
X
Definitions
Organization & Personnel
*
Responsibilities of quality control unit
Personal qualifications
…
…
*
Principles
Purpose of annex
Manufacturing in
3rd countries
Products authorized
in EU/EEA
…
…
TGA*
Pharma Quality System
Personnel
Premises & Equipment
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Formatting
Title Page
Citation
Outline
