Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council

Therapeutic Innovation & Regulatory Science
Yasuyuki HattoriYoshiaki Uyama

Abstract

In Japan, the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of the Ministry of Health, Labour and Welfare conducts discussions during the final stages of drug application reviews based on reports from the Pharmaceuticals and Medical Devices Agency (PMDA). Any disagreements or points of contention raised during these discussions can result in delays to drug approval. It is therefore important to characterize the points of discussion in the PAFSC meetings to optimize the process and enable more efficient drug approval reviews in Japan. We investigated the recorded minutes of PAFSC meetings concerning 229 drug applications (comprising 164 new drug applications and 65 supplemental applications) between fiscal years 2012 and 2014. The discussion points were characterized according to their main topics, and the frequency of each topic was examined. Clinical trials were the most frequent topic of discussion. Issues concerning package inserts were also prominent because many required reconsiderations and follow-up after council meetings. In particular, additional precautions and further clarification regarding drug indications and dosage were major points for reconsideration and follow-up. The review process may be improve...Continue Reading

References

Nov 1, 2008·Nature Reviews. Drug Discovery·Christian K Schneider, Gabriele Schäffner-Dallmann
Dec 28, 2011·Drug Metabolism and Pharmacokinetics·Yasuto OtsuboYoshiaki Uyama
Jun 30, 2012·Nature Reviews. Drug Discovery·Jeffrey F SmithPhilip Ma
Jul 9, 2014·The American Journal of Gastroenterology·Arthur A CiociolaUNKNOWN FDA-Related Matters Committee of the American College of Gastroenterology

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Citations

Aug 24, 2018·Globalization and Health·Mary WiktorowiczJoel Lexchin

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