FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA). In its defense, the FDA answers with a series of charts and graphs (PDF) that show that, on average, FDA has approved more novel new drugs, has approved these drugs more quickly, and has enabled these drugs to come to market sooner than its European counterpart. The FDA compared marketing approval of 57 novel drugs approved by both FDA and European Union regulators between 2006 and 2010. Of these, 43 were approved first in the United States and 14 were approved first by the E.U. Twenty-seven of these 57 drugs were FDA-designated priority review drugs that provide a therapeutic advance, and all but three of the 27 were approved first by FDA. The median time from marketing submission to FDA approval was 183 days for priority review products, and 396 days for standard review products. In the E.U., those times were 403 days and 449 days, respectively.
These facts show that the Food and Drug Administration’s review times are somewhat shorter and that approval of new drugs generally occurs sooner in the United States, compared with Europe. Despite these facts, the reality is that INDs are usually submitted to the E.U. first, with a seemingly more "accepting" agency and the industry’s conception continues that the approval gap (time between the E.U. and U.S.) will continue to widen as the FDA's requirements become more and more stringent. Margaret A. Hamburg, commissioner of the Food and Drug Administration, commented that “The review and approval of new drugs is not a race between FDA and E.U. regulators, with whom we collaborate and whom we see as colleagues. But we do operate under different laws and procedures. Finally, we note that apart from the FDA's regulatory climate, there are many reasons why industry chooses to work overseas, including reduced labor and production costs.”
Recently, on March 16, 2011, the FDA announced a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both the EMA and FDA. The parallel evaluation within this voluntary pilot program means that reviewers from both agencies will separately assess the quality/chemistry, manufacturing, and control (CMC) section of the new drug applications (NDAs) submitted to the FDA and marketing authorization applications (MAAs) submitted to the EMA. However, there will be regular communication and consultation between European regulators and their U.S. colleagues throughout the review process relevant to QbD aspects of the applications.
QbD in pharmaceuticals involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product manufacturing quality. Several guidelines have been developed by the International Conference on Harmonization (ICH) to harmonize and facilitate the implementation of QbD. This pilot program began out of concern that certain ICH guidelines were being interpreted differently in Europe and the United States. Goals of the pilot program include:
- Helping to ensure consistent implementation of ICH guidelines for manufacturing quality in the application evaluation process
- Increasing awareness of these regulatory concepts by staff that review marketing applications and inspect manufacturing facilities as part of the approval process
- Defining the reviewer and inspector interaction for QbD applications
- Creating a further way for EMA and FDA assessors/reviewers to share full knowledge about these applications
- Developing and harmonizing regulatory decisions to the greatest extent possible
This pilot program applies to NDAs and MAAs, some supplements, and CMC meeting requests that include QbD elements submitted to both agencies at about the same time. The pilot will only include chemical entities and not biologically derived products. Review of QbD applications does not change statutory deadlines. The pilot will end on March 31, 2014.
The race to Europe continues in spite of the positive steps by the FDA to streamline its approval process and the unchallenged claim of the FDA that its approval cycle is shorter compared to EMA.