FDA发布指南以防药品伪造

Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact John L. Smith 301-796-1757.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

July 2009

CMC

Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

Additional copies are available from:

Office of Communication

Division of Drug Information

Center for Drug Evaluation and Research

Food and Drug Administration

10903 New Hampshire Avenue

Bldg. 51, rm. 2201

Silver Spring, MD 20993-0002

(Tel) 301-796-3400

/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

July 2009

CMC

TABLE OF CONTENTS

I.INTRODUCTION (1)

II.BACKGROUND (2)

III.DESIGN CONSIDERATIONS FOR INCORPORATION OF PCID S IN SOLID ORAL DOSAGE FORMS (2)

A.Pharmacological and Toxicological Considerations (2)

B.Other Design Considerations (3)

IV.SUPPORTING DOCUMENTATION TO ADDRESS THE PROPOSED INCORPORATION OF PCIDs IN SOLID ORAL DOSAGE FORMS (4)

A.Documentation Regarding Incorporation of PCIDs into Solid Oral Dosage Forms to be

Included in any Premarketing or Postapproval Regulatory Submission (4)

B.Documentation Regarding Incorporation of PCIDs into Solid Oral Dosage Forms to be

Included in any Postapproval Regulatory Submission (4)

V.DETERMINING REPORTING CATEGORY FOR POSTAPPROVAL CHANGES TO INCORPORATE PCIDs INTO SOLID ORAL DOSAGE FORMS (5)

A.Reporting Categories (5)

1.Annual Report (6)

2.Changes Being Effected Supplement (6)

3.Prior Approval Supplement (6)

beling (6)

VI.POTENTIAL MIGRATION OF PCIDs ADDED TO PACKAGING OR CONTAINER LABELING (6)

rmation Regarding Toxicological and Other Concerns (7)

B.Reporting Categories for Adding PCIDs to Packaging or Container

Labeling Postapproval (7)

1.Annual Report (7)

2.Changes Being Effected Supplement (7)

3.Prior Approval Supplement (8)