Regulatory Open Forum

Hi all, 

After the Mutual Recognition Agreement, EMA does not inspect US establishments. 
I have a question on how to obtain a cGMP declaration from FDA for an establishment manufacturing a biologics (whose submission would go through CBER). 
I am aware of the CDEReCATS system to request cGMP declaration for a drug-manufacturing establishment. 
Does the same apply to biologics? Would I use the BECATS instead?

Thanks in advance!
Happy holidays :-)

Laura



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Laura Buffa
Thousand Oaks CA
United States
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​Hi Laura,

Yes, you would use CBEReCATs.

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Howard Yorek
Senior Director, Regulatory Affairs
Norcross GA
United States
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Original Message:
Sent: 14-Dec-2019 10:40
From: Laura Buffa
Subject: Biologics: cGMP declarations for US Establishments after MRA

Hi all,

After the Mutual Recognition Agreement, EMA does not inspect US establishments.
I have a question on how to obtain a cGMP declaration from FDA for an establishment manufacturing a biologics (whose submission would go through CBER).
I am aware of the CDEReCATS system to request cGMP declaration for a drug-manufacturing establishment.
Does the same apply to biologics? Would I use the BECATS instead?

Thanks in advance!
Happy holidays :-)

Laura



------------------------------
Laura Buffa
Thousand Oaks CA
United States
------------------------------