Dokumente
Europa English European Agencies EMA
02.10.2024
News
Improving efficiency of approval process for new medicines in the EU
EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union. The initiative aims to better manage the use of the network's expert resources, streamline assessment processes and encourage better and more comprehensive application dossiers from applicants at the time of initial submission. The overall objective of the initiative is to accelerate the availability of safe and effective...
EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union. The initiative aims to better manage the use of the network's expert resources, streamline assessment processes and encourage better and more comprehensive application dossiers from applicants at the time of initial submission. The overall objective of the initiative is to accelerate the availability of safe and effective treatments for patients. One of the areas identified as needing improvement is the reliability of long-term planning for initial marketing authorisation applications (MAAs). This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times. According to a recent report published by EMA:In 2023, the percentage of MAAs submitted on time (i.e. as per the date indicated on the letter of intent from the applicant) was only 35%. This is in line with 2018-2022 data, which indicates that each year only 30-40% of expected MAAs are submitted on the date indicated in the letter of intent.42% of companies seeking marketing authorisation in 2023 requested more time to respond to questions from EMA’s scientific committees during the assessment (also known as an ‘extended clock-stop’) because their data was not mature enough when it was submitted to EMA. In 2023, the average duration of clock-stops for initial MAAs (198...
Angaben ohne Gewähr. Stand: 02.10.2024