What’s going on with the backlog?
A quick summary of the key take-homes from the MHRA Established Medicines Clinic webinar.

Please note this is JensonR+’s interpretation of the feedback from the MHRA.

On the 16th of November 2023, members of the JensonR+ team attended the MHRA Established Medicines Clinic webinar. Here are some key points that the team at JensonR+ gathered:

Task and Finish Group:

Status and Objectives of the Task and Finish Group

  • The task and finish group remains active.
  • A subgroup within the larger group is dedicated to established medicines, aiming to enhance current practices and explore alternative approaches.
  • The group successfully made strides in reducing backlogs, but they acknowledge that the reduction did not meet the required level.

Backlog (Marketing Authorisation Application’s and Variations):

Status of Meeting Statutory Timelines and Marketing Authorisation Application Backlogs

  • They won’t meet statutory timelines for 2023 due to unforeseen challenges:
    • Higher volume of submissions than expected.
    • Resources in summer redeployed to support clinical trial application backlog.
    • Training new assessors takes a lot of resources.
  • Considering ‘Interim Milestones’ and additional metrics for enhanced visibility.
  • Planning to recruit 25 new assessors planned to address resource challenges.

Target Assessment Period and Backlog Details

  • Hope to meet statutory timelines for new Marketing Authorisation Applications in 2024.
  • Information on the backlog of UK Marketing Authorisation applications in the ‘Established Medicines’ category is not specified.

Assessor Assignment Timeframes and Quality Assurance Checks

  • Slower assessment due to clinical trials assessors leaving.
  • If a company has unusual delays in Quality Assurance checks; MHRA recommends direct communication to the agency for this to be reviewed.

Current Status of Type IA Variations and Concerned Member State Cases

  • Type IA variations on track to be cleared by the end of the year.
  • Focus groups established to target backlogs in Concerned Member State variations.

Type II Variations and Variation Query Response Times

  • Type II’s are being picked out to ensure medicine supply.
  • Delay time will be looked at and will be published. Typically talking a few months (90-150 days to currently turn around).
  • Improved handling of the variation query mailbox backlog.

Other updates:

Regulatory Management System Update

  • First release of Regulatory Management System this will include a portal and eCTD management system for the MHRA internally.
  • New system live by March 2024.

Scientific Advice Meeting Timelines

  • Normal Scientific Advice Meeting planning times expected to resume by Q4 2024.
At JensonR+, our team understands the intricacies of regulatory shifts and stands ready to provide specialised support for your business. If you seek assistance in ensuring compliance, managing your products, or addressing regulatory challenges, do not hesitate to reach out to our experts via business.development@jensongroup.com.
Lauren Foster
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