Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)

Table of Contents

1 INTRODUCTION

1.1 Objective
1.2 Scope and application
1.3 Policy statements
1.4 Definitions
1.5 Background

2 GUIDANCE FOR IMPLEMENTATION

2.1 General

2.1.1 Regulatory pathways
2.1.2 Indications
2.1.3 Reference biologic product
2.1.4 Review tim
2.1.5 Consultation with Health Canada

2.2 Information requirements for Clinical Trial Applications (CTA)

2.3 Information requirements for New Drug Submissions (NDS)

2.3.1 Quality requirements
2.3.1.1 Considerations for the comparability exercise
2.3.1.2 Quality considerations
2.3.1.3 Manufacturing process considerations
2.3.1.4 Determination of comparability/similarity
2.3.1.5 Organization of data
2.3.1.6 Changes post-approval

2.3.2 Clinical requirements
2.3.2.1 General
2.3.2.2 Pre-clinical studies
2.3.2.3 Clinical studies
2.3.2.4 Post market requirements

2.4 Information required for Supplementary New Drug Submissions (SNDS)

2.4.1 Information required for continuous product monitoring and post-market surveillance activities

2.5 Labelling requirements (Product Monograph)

2.6 Harmonization with other international regulators

Template for the Submission of Comments Draft Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) Distributed for Consultation Purposes

Template for the Expression of Interest in Participating In the May, 2008 Consultation

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