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. We can't pay in into anyone else's bank account.Daniel Sanchez and Yin Ho explore the concept of cycle time in regulatory decisions in the pharma industry and their significance in market access. This letter will tell you how long we'll take to deal with your application.
We'll write to you to confirm your application. If you apply after the 29 February 2024, your EMA will be paid from the date your application was received. If you apply before 29 February 2024, we'll backdate EMA to the start of that term. If you apply after the 30 September 2023, your EMA will be paid from the date your application was received. If you apply before 30 September 2023, we'll backdate EMA to the start of the school year. your household income is within the agreed government levelsĭownload an EMA application form (PDF) (opens new window)Ĭompleted applications can be posted to the Barrhead Main Street office or can be submitted with pictures of all relevant documents to the EMA team.you sign a learning agreement with your school.your study involves at least 21 hours of guided learning a week.your birthday is between 1 March 2004 and 28 February 2008.You qualify for an EMA for the 2023/24 school year if:.
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