FDA and Health Canada streamline drug submissions

INICIO/Políticas y legislación | Posted 28/02/2014 post-comment0 Post your comment

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system.

Shaking hands V13D29

The system uses secure Internet connections to receive electronic versions of medical product applications and related documents from industry sponsors seeking regulatory approval. FDA’s Electronic Submissions Gateway has been running since 2006 and this latest modification allows it to receive submissions from Canada as well as the US, using the same interface and technology. Submissions can then be transmitted to one or both regulatory authorities.

The gateway is an outcome of the US–Canada Regulatory Cooperation Council, which was first announced by US President Barack Obama in February 2011. Thus, it has progressed from concept to delivery in only 26 months.

‘By streamlining the process to allow industry to submit information in an easy and secure manner, Canadians will benefit from faster access to safe and effective medications. This will encourage more companies to bring their products to Canada,’ said Canada’s Minister of Health, Rona Ambrose.

The collaboration should yield long-term positive outcomes for both FDA and Health Canada, streamlining both agencies’ submission requirements while maintaining consistency in regulatory requirements. There could also be cost savings for regulated industry, which would not have to follow separate technical requirements for submission to the two countries.

This is not the first collaboration FDA is carrying out with other regulatory agencies. This announcement follows a previous initiative announced by FDA to collaborate with the European Medicines Agency, which provides a mechanism to conduct joint facility inspections for generics applications submitted to both agencies [1].

‘This is yet another example of the steps FDA is taking as part of our Global Initiative, which envisions enhanced collaboration with our regulatory partners,’ said Dr Robert Yetter, Associate Directory for Review Management in FDA’s Center for Biologics Evaluation and Research.

Related articles

Pilot programmes between EMA, FDA and TGA a success

EMA, FDA and TGA joint GMP inspection programme


1.   GaBI Online - Generics and Biosimilars Initiative. EMA and FDA launch joint generics inspections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 28]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-launch-joint-generics-inspections

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.

Source: FDA, US Dept of Commerce

comment icon Comments (0)
Post your comment
Related content
Consulta pública para la modificación de la regulación de biosimilares
02 AA010638
INICIO/Políticas y legislación Posted 16/01/2024
COFEPRIS promueve la cooperación regulatoria en América
Latin America 1638px
INICIO/Políticas y legislación Posted 12/12/2023
Pendiente la decisión de ANVISA sobre las ‘skinny labels’ para genéricos
Labelling V14I26
INICIO/Políticas y legislación Posted 14/11/2023
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010