Sage Journals: Discover world-class research

Abstract

This paper highlights the structure and content of the clinical sections of the United States, European, and Japanese submissions with emphasis on the clinical summaries that are used by the three regional regulatory authorities for their assessment of registration dossiers. The comparative analysis of the three clinical summaries dealing with efficacy and safety results shows a high level of similarities in content, despite the cultural and medical differences, as well as differences in assessment approaches and legal requirements in the three regions. The different assessment approaches as well as the different ways to obtain advice regarding drug development leading to registration are also evaluated.

Keywords

Common Technical Document;Clinical summaries;Assessment approaches;Scientific advice in the United States Europe and Japan

Get full access to this article

View all access options for this article.

References

FDA—US New Drug Application—NDA (21 CFR section 314.50).

FDA—US New Drug Application Summary—NDA (21 CFR section 314.50(c)).

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. (OJ No L 147 of 9.6.1975).

Commission Directive 91/507/EEC of 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. (OJ No L 270 of 26.9.1991).

Notification MHW/PAB, N°698, May 30, 1980. Issued by the Director General of Pharmaceutical Affairs Bureau, Japanese NDA submission.

Pharmaceutical Affairs Law: Art 14–3. Japan.

The Guiding Principles for preparing the Document Summary (GAIYO) of Applications for Approval of New Drugs. Japanese NDA, Summary Basis of Approval, SBA. MHW/PAB/NDD, N°21 dated March 31, 1992.

Summary Basis of Approval—SBOA (21.CFR 314.430 (e)ii).

Guideline for the format and content of the Clinical and Statistical sections of new drug application. Rockville, MD: Department of Health and Human Services, US Food and Drug Administration, Center for Drug Evaluation and Research; July 1988.

10.

Notice to Applicants—Medicinal products for human use—Presentation and content of the dossier. Volume 2 B, European Commission, 1998 Edition.

11.

European Public Assessment Report (EPAR). Council Regulation (EEC) N° 2309/93 Art 12.

12.

FDA-IND (21 CFR 310.3).

13.

FDA-IND for new use or a significant change in labeling or advertising (21 CFR 312.2).

14.

CPMP/SOP/002/95. Scientific Advice to be given by the CPMP for innovative Medicinal Products. Adopted February 1996.

15.

E3—ICH Guideline—Structure and Content of Clinical Study Reports. CPMP/ICH/137/95. International Conference on Harmonization, Yokohama, Japan; 1995.

16.

M2—Electronic Standards for the Transfer of Regulatory Information (ESTRI). International Conference on Harmonization, Brussels, Belgium; 1997.

ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States,Europe,and Japan *

Abstract

Keywords

Get full access to this article

References