EMEA and FDA guidelines [Regulatives / Guidelines]
Hello Chintan,
it’s simply not possible to list everything here in the forum – somewhere in the depths of the database I have set a limit to the length of posts.
Essentially there are more similarities than differences.
Generally European Guidelines are more flexible and leave more space for interpretation, although the current regulatory practice – at least in some countries – became more restrictive in the last couple of years.
You may find the Guidance page helpful:
EU-EMEA Guidelines and Regulations
US-FDA Guidelines and Regulations
If you have more specific questions, don’t dare asking in the forum!
it’s simply not possible to list everything here in the forum – somewhere in the depths of the database I have set a limit to the length of posts.

Essentially there are more similarities than differences.
Generally European Guidelines are more flexible and leave more space for interpretation, although the current regulatory practice – at least in some countries – became more restrictive in the last couple of years.
You may find the Guidance page helpful:
EU-EMEA Guidelines and Regulations
US-FDA Guidelines and Regulations
If you have more specific questions, don’t dare asking in the forum!
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- differences between EMEA and FDA guidelines chintan98 2006-07-12 09:18
- EMEA and FDA guidelinesHelmut 2006-07-12 12:32