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