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Abstract

The approval time is defined as the time between the submission date and the approval date and is a regulatory performance measure commonly used in international comparisons. The Japanese Office of Pharmaceutical Industry Research conducted a survey in 2003 to collect unpublished data on approval times of recently approved new drugs in Japan. The results of the survey, which targeted 315 new drug applications (NDAs) approved between 1996 and 2002, showed that the Japanese median approval times were reduced significantly from 41.3 months in 1998 to 17.7 months in 2002 by an approval cohort analysis. When compared with approval times in other countries, Japanese approval times have been gradually approaching those in the United States and the European Union, especially since the establishment of a new review agency in 1997. The reduction in approval times seemed to be achieved by internalizing the review process instead of utilizing external resources. The approval times varied between NDAs with different properties, even though the same performance goals were applied to them.

Keywords

Japan Pharmaceuticals and Medical Devices Evaluation Center New Drug Application (NDA)Approval times Reviewing agency

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References

Fujiwara

MD reviewers' role in the new anticancer drug approval process in the newly established Japanese regulatory agency, PMDEC. Jpn J Clin Oncol. 1998;28:653–656.

Fujiwara

Kobayashi

Oncology drug clinical development and approval in Japan: The role of the pharmaceuticals and medical devices evaluation center (PMDEC). Critical Rev Oncol Hematol. 2002;42:145–155.

Pharmaceutical and Medical Devices Agency. Press release on the new review agency [in Japanese]. http://www.pmda.go.jp/press_31.html. (Accessed June 29, 2004).

Center for Drug Evaluation and Research. CDER 2002 Report to the Nation, http://www.fda.gov/cder/reports/rtn/2002/rtn2002.htm. (Accessed Feb 17, 2004).

Reichert

Trends in development and approval times for new therapeutics in the United States. Nature Rev. 2003;2:695–702.

Kaitin

Cairns

The New drug approvals of 1999, 2000, 2001: Drug development trends a decade after the passage of the Prescription Drug User Fee Act of 1992. Drug Inf J. 2003; 37:357–371.

The European Agency for the Evaluation of Medicinal Products. EMEA 8th annual report 2002 [online]. http://www.emea.eu.int/pdfs/general/direct/emeaar/005502en.pdf. (Accessed Feb 17, 2004).

Center for Drug Evaluation and Research (CDER). CDER guide to median approval time statistics. http://www.fda.gov/cder/present/MedianAPtime/index.htm. (Accessed Dec 3, 2003).

Yoshino

Clinical and Pathophysiological Background between Japan and Western Countries in the fields of Neurology and Psychiatry [in Japanese). Clin Eval. 2001;28:81–83.

10.

Balant

Balant-Gorgia

: Cultural differences: Implications on drug therapy and global drug development. Int J Clin Pharmacol Ther. 2000;38:47–52.

11.

Peck

Rubin

Sheiner

Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin Pharmacol Ther. 2003;73:481–490.

12.

Rawson

NSB

Kaitin

Canadian and US drug approval times and safety considerations. Ann Pharmacother. 2003;37:1403–1408.

13.

Tominaga

Narukawa

Commentary on notifications of the Ministry of Health [in Japanese]. In: Changing International Strategies for New Drug R&Ds. Tokyo: Yakugyo-jiho; 1998.

14.

Pignatti

Aronsson

Gate

The review of drug applications submitted to the European Medicines Evaluation Agency: Frequently raised objections, and outcome. Eur J Clin Pharmacol. 2002;58:573–580.

15.

DiMasi

Manocchia

Initiatives to speed new drug development and regulatory review: The impact of FDA-sponsor conferences. Drug Inf J. 1997;31:771–788.

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

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