FDAICH Public Meeting

5630 Fishers Lane, Rockville, MDMay 8, 2001

10:30 am -- 2:00 pm

Implementation of the CTDUpdate-Issues-Next Steps

Justina A. Molzon, M.S. Pharm., J.D.Associate Director for International AffairsCenter for Drug Evaluation and Research

U.S. Food and Drug Administration

CTD Expert Working Groups

SAFETY EFFICACY

QUALITY REGULATORY COMMUNICATIONS

The CTD is the result of much hard work by many individuals

Organization of the CTD• Module 1: Regional information• Module 2: Quality Overall Summary

Nonclinical Overview and Summary Clinical Overview and Summary

• Module 3: Quality• Module 4: Nonclinical Study Reports• Module 5: Clinical Study Reports

The CTD Triangle

Module 1

RegionalAdmin

Information

Module 3Quality

Module 4

NonclinicalStudy Reports

Module 5

ClinicalStudy Reports

QualityOverall

SummaryNonclinicalSummary

NonclinicalOverview

ClinicalSummary

ClinicalOverview

Module 2

NOT Part of the CTD

The CTD

eCTD• Six months behind CTD• The eCTD will be a transport

format intended to be moved into an agency’s review environment.

• Step 2 targeted for ICH meetings in Tokyo, May of 2001

CTDImplementation Issues

• Each ICH region is in the process of developing an implementation program

• Promote consistency between regions• Transparency important• Communication of progress on a

regular basis

CTDImplementation Efforts

• Discussed by the Regulators at ICH5• Developed--Regulators Considerations

for Implementation of the CTD– Harmonized and synchronized approach– Identify topics and mechanisms for

discussion amongst regulators– Work with industry to establish

implementation/monitoring task force(s)

CTDImplementation Efforts

• Target Date for acceptance for CTD – July 2001

• Voluntary submission

CTDImplementation Issues -

FDA • Determining how the final CTD fits

into our current regulatory scheme.

• May need changes in regulations. • Considering general waiver.

CTDImplementation Questions -

FDA• How to incorporate region specific

information into the CTD• How to relate the CTD submission

to information currently required• How to apply the CTD to other FDA

submissions for consistency

CTDImplementation Specifics-

FDAGeneral Considerations

Guidance• Guidance for Industry• General Considerations for

Submitting Marketing Applications According to the ICH/CTD Format

• To be issued in time for voluntary submission of applications in the CTD format

CTDImplementation Specifics-

FDA

General Considerations Guidance• What we expect to be submitted

• Physical description of submission • CTD requirements addressed• List obsolete guidances • Logistics of submission• Timeframe

CTDImplementation Specifics-

FDAGeneral Considerations

GuidanceModule 1• Administrative & Prescribing Information includes:

– FDA form 356h– Cover letter– Patent information– Debarment Certification– Field Copy certification– User Fee cover sheet– Financial disclosure information

CTDImplementation Specifics-

FDAGeneral Considerations

Guidance• Administrative and Prescribing Information Continued…– Letters of authorization for reference to

other applications or drug master files– Patent Certification (not for BLA)– Waiver requests– Claimed Exclusivity– Labeling (package insert)– Container and package labels– Annotated labeling

CTDImplementation Specifics-

FDAGeneral Considerations

Guidance• General Issues for Submissions– Amendments and supplements– Organizing documents– Number of copies

• Archival• Review• Field

– Paper size– Paper margins– Fonts

CTDImplementation Specifics-

FDAGeneral Considerations

Guidance• General Issues for Submissions continued– Binding volumes– Binder colors– Volume size– Volume identification– Pagination– Packing carton– Address for submission

CTD Implementation Specifics-

FDATraining and Transparency

• Train reviewers and document room staff

• Map current process to that required by the CTD

• Create feedback mechanism for industry

• Provide updates on progress

THANK YOU