Journal Article

Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

Shah, Nilay D, Krumholz, Harlan M, Braunstein, Joel B, Downing, Nicholas S, Aminawung, Jenerius A, Ross, Joseph S

2012

Overview

In this study of the review time for new-drug applications for novel therapeutics approved in the United States, Canada, and Europe from 2001 through 2010, the FDA completed reviews more quickly than did the European Medicines Agency (EMA) and Health Canada. The Prescription Drug User Fee Act (PDUFA) of 1992 was enacted to augment the resources of the Food and Drug Administration (FDA) that are devoted to reviewing applications for drugs for humans and to ensuring drug efficacy and safety. 1 In exchange for meeting clear performance standards, the FDA is authorized by PDUFA to collect user fees for each new application to support the infrastructure needed for review, such as the hiring of additional staff. Although PDUFA has contributed to a substantial reduction in the review times for drug applications over the past two decades, 2 , 3 meeting these performance standards has . . .

• Publisher: Massachusetts Medical Society
• Subject: Biological and medical sciences / Canada / Commerce / Drug Approval - economics / Drug Approval - organization & administration / Drug Industry - economics / Europe / FDA approval / Fees and Charges / General aspects / Government Agencies / Government Regulation / Humans / Medical sciences / Miscellaneous / Pharmaceutical industry / Prescription drugs / Prescription Drugs - economics / Public health. Hygiene / Public health. Hygiene-occupational medicine / Regulatory agencies / Reviews / Time Factors / United States / United States Food and Drug Administration