My presentation on eSubmissions and eMDR Proposed Rule at Medtec China 2011

1. US FDA Regulation Update Electronic Submissions Presented by John Beasley

2. Topics Electronic Submissions FDA Electronic Submission Gateway (ESG) CDRH initiatives eSubmitter / WebTrader Software Video

3. Introduction

4. Introduction 便宜 但好

5. Introduction Drugs (Regulated by CDER) - Over-the-Counter medications - Prescription Drugs - Generic Drugs Biologics (Regulated by CBER) - Vaccines - Blood - Gene Therapies Food & Cosmetics (Regulated by CFSAN) - Food products (excluding meat) - Food additives (colors, fortifications, radiation) - Dietary Supplements - Bottled Water - Food packaging and labeling - Cosmetics Medical Devices (Regulated by CDRH) - Wheelchairs - Bandages - Contact Lenses - Prosthetic Limbs - MRI Machines Radiation-Emitting Products (Regulated by CDRH) - Microwave Ovens - Televisions - Medical X-ray machines - Baggage X-ray machines Veterinary Products (Regulated by CVM) - Livestock Feed - Pet Food - Animal Drugs

6. 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)

7. Electronic Submissions STDM – statistical time division multiplexing HL7 – standards for interoperability of health information technology

8. 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).

9. Electronic Submissions

10. Electronic Submissions A D V E R S E E V E N T S

11. Electronic Submission 21 CFR 333 21 CFR 880.6890

12. Electronic Submissions Gateway Receiptmeans transfer of a submission from a sender’s system to a temporary storage area in the GATEWAY (FDA ESG). Acknowledgmentto the sender that the submission was sent from the sender’s system and received by the Gateway. Routingrefers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system Notificationof a submission’s arrival is made to those individuals responsible for the Center’s receiving system.

13. Electronic Submissions Gateway The Gateway is a conduit, or "highway", along which submissions travel to reach their final destination.

15. Less expensive

16. Greater accuracy

17. Fast

19. Preparing for ESG 胆小或大胆

20. FDA’s Electronic Submission Gateway Letter of non-repudiation DUNS number Digital certificate Prepare electronic submission Set up the computer Letter of Non-repudiation AS2 Gateway to Gateway ESG Digital certificate eSubmitter & WebTrader

21. US FDA Webinar – June 2011