MHRA Applications – One strike and it’s out
Earlier this year the MHRA published new guidance on established medicines, the guidance came into force on 1st March 2024. The aim of the guidance is to ensure that applications are right first time, which allows for timely processing of marketing authorisation applications for establishes medicines and applies specifically to chemical products.
The main changes are that the MHRA:
Depending on the status of your application, as in whether an assessment has begun or not, the MHRA will take a slightly different approach and the details of this can be found on the MHRA website.
Some of the changes are to put more emphasis on the applicant to provide a complete and thoroughly checked application; therefore applicants will need to ensure their submissions are of high quality and possibly put into place additional quality checks.? The third point on the list above relates to completing the UKPAR, all the templates for the relevant legal basis are available on the MHRA website and it is something that the applicant can look at ahead of the anticipated approval and ensure this step is now included in their process.
There are a number of ways the MHRA are supporting industry with this change.? There are Checklists available on the MHRA website as well as a list of ‘common application flaws’. In addition, Regulatory Information Service (RIS) remains the main point of contact for information and support for applicants.
To see how this will improve assessment timelines you can take a look at the MHRA performance data.
The MHRA have stated that “The measures we have put in place are already resulting in significant improvement, and we will continue to publish monthly updates providing applicants with transparent information on expected timescales”.
We will have to keep an eye on the performance data to determine whether this change has made a significant impact to clear the backlog and ensure applications are assessed within the statutory timescales.
Written by Nosheen M.