12/26/2023 0 Comments Ema start timeAt the end of their evaluation process, the EMA puts forth an opinion for market authorization that is known as a non-binding Committee for Medicinal Products for Human Use (CHMP) recommendation-a non-binding opinion. In Europe, the EMA's process involves one more step, creating an intermediate time point that seems to be mistakenly calculated as the point of market authorization for a drug in Europe. So for the FDA, the time of approval as the endpoint for market authorization is appropriate. Almost immediately after the FDA grants approval, the drug is authorized for marketing, and made available to the U.S. In the U.S., FDA cycle times are calculated from the time a drug is submitted for approval to when it is granted approval. Based on this discrepancy, we believe that some of the comparisons that determine the agency's cycle time or speed to market may be incorrect. Looking across the past four years of regulatory decisions by both the FDA and EMA, we found that some cycle time analyses published for the EMA actually used a different endpoint than the one that determines market authorization. This perspective is one that is driven from a lack of understanding about the difference between the two processes and represents an FDA-centric point of view. When comparing the FDA and EMA, we found that many of the calculations that determine this relative speed have used time of approval and time of market authorization, interchangeably. However, the time of approval of a drug may not necessarily be equivalent to the time of market authorization-which is a more important time point because it is when a drug becomes available to be prescribed. Understanding cycle times: are we all using the same math?Ĭycle times calculate the time of approval for a drug. "Adding an extra two months to market could make a tremendous difference, especially for life-saving drugs." One of the most interesting things we found was about how cycle times are calculated, and that they are not always measured the same way. Last year we wrote a three-part series, " Life in the Fast Track" that looked into how the speed of previous FDA fast lanes compared with the EMA. There has been a lot of discussion and interest lately about the length and speed of cycle times for drug development, specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Adding an extra two months to market could make a tremendous difference, especially for life-saving drugs. In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint, which resulted in cycle times that looked two months shorter than they actually are. The date of approval is generally the point in time when a drug is considered eligible for market access. In the U.S., this is the time that it takes to get a drug approved by the FDA. A cycle time measures the time from the date of submission, through date of approval. They consider the FDA compared with the EMA in this context and question whether we are comparing them fairly.Ĭycle times for regulatory decisions are of great importance, especially in understanding market access for a drug. Daniel Sanchez and Yin Ho explore the concept of cycle time in regulatory decisions in the pharma industry and their significance in market access.
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