Module 3 - Strategic case studies in practice

Correlation Table :

EU-CTD (NTA, Vol. 2B, edition May 2006 ) vs. NTA, Vol. 2B (edition 1998)

MODULE 1 - ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION

CTD

EU CTD (NTA, Vol. 2B, Edition 2006)

NTA, Vol. 2B (Edition 1998)

NTA

1.0 1.1 1.2

Cover Letter

Comprehensive table of content

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Application Form

Administrative Data

I A

1.3

Product Information

Summary of Product Characteristics, Labelling and Package Leaflet

I B

1.3.1

Summary of Product Characteristics, Labelling and Package Leaflet

Summary of Product Characteristics

I B 1

Proposal for packaging, labelling & package leaflet

I B 2

1.3.2 1.3.3 1.3.4 1.3.5

Mock-up Specimen

I B 2

Consultation with Target Patient Groups

Product Information already approved in the Member States

SPCs already approved in the Member States

I B 3

1.3.6

Braille

1.4

Information about the Experts

Expert Reports: Signature of Experts

I C

1.4.1 1.4.2 1.4.3

Quality

Non-clinical

Clinical

1.5

Specific Requirements for different types of applications Information for bibliographical applications Information for Generic, “Hybrid” or Bio-similar Applications

--- --- ---

1.5.1 1.5.2

1.5.3 1.5.4 1.5.5

(Extended) Data/Market Exclusivity

Exceptional Circumstances

Conditional Marketing Authorisation

1.6

Environmental risk assessment

Environmental risk assessment

Environmental risk assessment / ecotoxicity (for non- GMOs) Data related to the environmental risk assessment for products containing, or consisting of genetically modified organisms (GMOs)

1.6.1

Non-GMO

III R

1.6.2

GMO

II H

1.7

Information relating to Orphan Market Exclusivity

1.7.1 1.7.2

Similarity

Market Exclusivity

1.8

Information relating to Pharmacovigilance

1.8.1 1.8.2

Pharmacovigilance System Risk-management System

1.9

Information relating to Clinical Trials Responses to Questions

Responses to Questions

NTA, Vol. 2B-CTD, foreword & introduction, edition June 2006

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