US FDA Regulation Update
Electronic Submissions
Presented by John Beasley
Topics
• Electronic Submissions• FDA Electronic Submission Gateway
(ESG)• CDRH initiatives• eSubmitter / WebTrader Software• Video
Introduction
Introduction
便宜但好
IntroductionDrugs (Regulated by CDER) - Over-the-Counter medications- Prescription Drugs- Generic DrugsBiologics (Regulated by CBER) - Vaccines- Blood- Gene TherapiesFood & Cosmetics (Regulated by CFSAN)- Food products (excluding meat)- Food additives (colors, fortifications, radiation)- Dietary Supplements- Bottled Water- Food packaging and labeling- CosmeticsMedical Devices (Regulated by CDRH)
- Wheelchairs- Bandages- Contact Lenses- Prosthetic Limbs- MRI MachinesRadiation-Emitting Products (Regulated by CDRH) - Microwave Ovens- Televisions- Medical X-ray machines- Baggage X-ray machinesVeterinary Products (Regulated by CVM) - Livestock Feed- Pet Food- Animal Drugs
Electronic Submissions
• 1997 – Computer Assisted New Drug Applications
• 2001 – Providing Regulatory eSubmissions for NDAs, BLAs, ANDAs
• 2007 – CDRH e-copy initiatives; turbo 510(k) for IVD products
• 2011 – eMDR (21 CFR 803)
Electronic Submissions
• STDM – statistical time division multiplexing
• HL7 – standards for interoperability of health information technology
Electronic Submissions
• FDA Electronic Submission Gateway– Federal Register: August 8, 2006 (Volume
71, Number 152) – A single point of entry for receiving and
processing all electronic submissions in a highly secure environment,
– Automating current processes such as the electronic acknowledgment of submissions, and
– Supporting the electronic Common Technical Document (eCTD).
2006 2007 2008 2009 2010 2011 (projected)0
100000
200000
300000
400000
500000
600000
700000
800000
900000
1000000
Total eSubmissions
Electronic Submissions
Electronic Submissions
ADVERSE
EVENTS
Electronic Submission
21 CFR 333 21 CFR 880.6890
Electronic Submissions Gateway
• Receipt means transfer of a submission from a sender’s system to a temporary storage area in the GATEWAY (FDA ESG).
• Acknowledgment to the sender that the submission was sent from the sender’s system and received by the Gateway.
• Routing refers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system
• Notification of a submission’s arrival is made to those individuals responsible for the Center’s receiving system.
Electronic Submissions Gateway
The Gateway is a conduit,
or "highway", along which submissions
travel to reach their final
destination.
Electronic Submissions Gateway
• Six to eight weeks to setup• Less expensive• Greater accuracy• Fast• Better evidence
What’s in it for you?
• Collaboration• Cost reduction• Record retention• Responsiveness• Single environment for all AE
Preparing for ESG
胆小或大胆
FDA’s Electronic Submission Gateway
AS2 Gateway to Gateway
eSubmitter & WebTrader
Digital certificate
ESG
Letter of non-repudiation
1. DUNS number2. Digital certificate3. Prepare electronic
submission4. Set up the
computer5. Letter of Non-
repudiation
US FDA Webinar – June 2011