Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-08-24 01:11 CEST (UTC+2h)
 
Helmut
Hero
Homepage
Vienna, Austria,
2017-03-03 11:42

Posting: # 17124
Views: 667
 

 GMP: EMA and FDA – mutual recognition of inspections [GxP / QC / QA]

Dear all,

regulators in the European Union (EU) and the United States (US) have agreed to recognize inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic – see yesterday’s press releases (EMA, FDA) and the full text of the agreement.

[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
nobody
Senior

2017-03-03 16:15

@ Helmut
Posting: # 17129
Views: 527
 

 GMP: EMA and FDA – mutual recognition of inspections

...to avoid double-inspections and put more focus on other regions.

Kindest regards, nobody
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,243 Posts in 3,687 Threads, 1,056 registered users;
18 users online (0 registered, 18 guests).

I try not to think with my gut.
If I’m serious about understanding the world,
thinking with anything besides my brain, as tempting as that might be,
is likely to get me into trouble.    Carl Sagan

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed