EMEA and FDA guidelines [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2006-07-12 14:32 (6790 d 21:30 ago) – Posting: # 167
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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!

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