A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They create additional workload for companies and potential delays at a critical moment for the timely start of the procedure. To make the validation process more efficient, predictable and easier to navigate, EMA is encouraging applicants to submit Package a new validation checklist as part of the MAA dossier.
The initiative is launched as a five-month pilot and is expected to increase the number of ‘first time right’ submissions significantly. Applicants who use the checklist are invited to submit their comments to This email address is being protected from spambots. You need JavaScript enabled to view it.. EMA will use this feedback and the information collected on the quality of submissions using the new checklist to improve the validation process itself.
The checklist includes a number of questions that will help companies to assess the level of completion and consistency of the various sections in their applications. More information can be found in the updated Pre-authorisation guidance questions and answers (Q&A) on the website.
In addition, EMA has also updated the Q&A section on inspections and compliance with an updated form on good clinical practice (GCP) as well as clarification on statements required in the cover letter for good manufacturing practice (GMP). These will help companies to structure the relevant information required for the organisation of future inspections.
After completion, EMA will analyse the result of the pilot and inform stakeholders about the conclusion in the second half of 2019.