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MHRA performance data for assessment of clinical trials and established medicines

MHRA performance metrics for clinical trials and established medicines assessment.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
14 April 2023
Last updated:
14 February 2025
Show all updates

  1. Added February performance data, including updates to HTML page for MHRA performance data for assessment of clinical trials and established medicines.

  2. Updated performance Metrics for December 24

  3. added updated performance data and revised wording of HTML attachment, also to include link to clinical trials legislation the previous day More recently, changed 1b to 1a in the Variations section

  4. Webinar link for 17 October 2024 added to MHRA performance data for assessment of clinical trials and established medicines page.

  5. Added new performance metrics Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – November 2024) (Clinical Investigations – September 2023 – November2024) - file attachment created Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - November 2024) - file attachment created MHRA performance data for assessment of clinical trials and established medicines - HTML attachment updated

  6. Updated Performance metrics for October 2024

  7. Added Performance data for September 2024

  8. Published: Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - July 2024) Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – June 2024) (Clinical Investigations – July 2023 – July 2024)

  9. Published: Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – June 2024) (Clinical Investigations – July 2023 – June 2024) Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - June 2024)

  10. Added Performance Metrics: Assessment of Clinical Trial Authorisation Applications and performance Metrics: Assessment of New Marketing Authorisation Applications and Variations and updated HTML to reflect updates.

  11. Published - Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials: September 2023 - April 2024) (Clinical Investigations: May 2023 - April 2024) and - Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - April 2024)

  12. Published 'Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials: September 2023 - March 2024) (Clinical Investigations: April 2023 - March 2024) & Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - March 2024)

  13. Published Clinical Trials Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (February 2023 – February 2024) & Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 – February 2024).

  14. Published 'Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 – January 2024)' & 'Clinical Trials Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (February 2023 – January 2024)'

  15. Published 'Performance Metrics January 2023 – December 2023: Assessment of New Marketing Authorisation Applications and Variations' and 'Clinical Trials Performance Metrics: December 2022 - December 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments'

  16. Published 'Clinical Trials Performance Metrics: December 2022 - November 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments' and 'Performance Metrics January 2023 – November 2023: Assessment of New Marketing Authorisation Applications and Variations'.

  17. Published 'Clinical Trials Performance Metrics: November 2022 - October 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments' & 'Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations'

  18. Published 'Clinical Trials Performance Metrics: October 2022 -September 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments' and 'Performance Metrics January 2023 – September 2023: Assessment of New Marketing Authorisation Applications and Variations'.

  19. Published 'Clinical Trials Performance Metrics: September 2022 - August 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments' and 'Performance Metrics January 2023 – August 2023: Assessment of New Marketing Authorisation Applications and Variations'

  20. Published 'Clinical Trials Performance Metrics: August 2022 to September 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments'

  21. Published 'Clinical Trials Performance Metrics: July 2022 - July 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments' & 'Performance Metrics January 2023 – June 2023: Assessment of New Marketing Authorisation Applications and Variations'

  22. Added: Clinical Trials Performance Metrics: July 2022 - June 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments - file attachment & Performance Metrics January 2023 – June 2023: Assessment of New Marketing Authorisation Applications and Variations - file attachment

  23. Added 'Clinical Trials Performance Metrics: June 22 - May 23' and 'Performance Metrics January 23 – May 23: Assessment of New Marketing Authorisation Applications and Variations'

  24. Added latest performance metrics for 'Assessment of Clinical Trial Authorisation Applications and Substantial Amendments' and 'Assessment of New Marketing Authorisation Applications and Variations'

  25. First published.

Documents

MHRA performance data for assessment of clinical trials and established medicines

HTML

Performance Metrics Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – February 2025) (Clinical Investigations – September 2023 – February 2025)

PDF, 529 KB, 18 pages

Performance Metrics Assessment of New Marketing Authorisation Applications and Variations (January 2023 - February 2025)

PDF, 201 KB, 3 pages

Performance Metrics Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – December 2024) (Clinical Investigations – September 2023 – January 2025)

PDF, 562 KB, 18 pages

Performance Metrics Assessment of New Marketing Authorisation Applications and Variations (January 2023 - January 2025)

PDF, 188 KB, 3 pages

Performance Metrics Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – November 2024) (Clinical Investigations – September 2023 – December 2024)

PDF, 550 KB, 18 pages

Performance Metrics Assessment of New Marketing Authorisation Applications and Variations (January 2023 - December 2024)

PDF, 201 KB, 3 pages

Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – November 2024) (Clinical Investigations – September 2023 – November2024)

PDF, 563 KB, 18 pages

Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - November 2024)

PDF, 200 KB, 3 pages

Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - October 2024)

PDF, 201 KB, 3 pages

Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – October 2024) (Clinical Investigations – September 2023 – October 2024)

PDF, 652 KB, 18 pages

Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – August 2024) (Clinical Investigations – September 2023 – August 2024)

PDF, 628 KB, 19 pages

Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - July 2024)

PDF, 189 KB, 3 pages

Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - August 2024)

PDF, 202 KB, 3 pages

Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – June 2024) (Clinical Investigations – July 2023 – July 2024)

PDF, 670 KB, 18 pages

Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - June 2024)

PDF, 201 KB, 3 pages

This file may not be suitable for users of assistive technology.

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Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials - September 2023 – June 2024) (Clinical Investigations – July 2023 – June 2024)

PDF, 535 KB, 18 pages

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Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials: September 2023 - May 2024) (Clinical Investigations: May 2023 - May 2024)

PDF, 506 KB, 18 pages

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Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - April 2024)

PDF, 200 KB, 3 pages

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Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - May 2024)

PDF, 202 KB, 3 pages

Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials: September 2023 - April 2024) (Clinical Investigations: May 2023 - April 2024)

PDF, 524 KB, 18 pages

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Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (Clinical Trials: September 2023 - March 2024) (Clinical Investigations: April 2023 - March 2024)

PDF, 525 KB, 18 pages

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Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 - March 2024)

PDF, 305 KB, 5 pages

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Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 – February 2024)

PDF, 304 KB, 5 pages

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Clinical Trials Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (February 2023 – January 2024)

PDF, 471 KB, 18 pages

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Clinical Trials Performance Metrics: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Amendments (February 2023 – February 2024)

PDF, 440 KB, 18 pages

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Performance Metrics: Assessment of New Marketing Authorisation Applications and Variations (January 2023 – January 2024)

PDF, 302 KB, 5 pages

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Clinical Trials Performance Metrics: December 2022 - December 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments

PDF, 624 KB, 18 pages

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Performance Metrics January 2023 - December 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 301 KB, 5 pages

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Clinical Trials Performance Metrics: December 2022 - November 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments

PDF, 473 KB, 17 pages

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Clinical Trials Performance Metrics: November 2022 - October 2023: Assessment of Clinical Trial Authorisation Applications, Clinical Investigations and Substantial Amendments

PDF, 472 KB, 17 pages

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Performance Metrics January 2023 – November 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 1.2 MB, 24 pages

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Performance Metrics January 2023 – October 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 1.22 MB, 24 pages

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Clinical Trials Performance Metrics: September 2022 - August 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 518 KB, 14 pages

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Clinical Trials Performance Metrics: October 2022 -September 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 495 KB, 23 pages

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Performance Metrics January 2023 – September 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 1.18 MB, 24 pages

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Performance Metrics January 2023 – August 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 1.22 MB, 24 pages

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Clinical Trials Performance Metrics: August 2022 to September 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 531 KB, 15 pages

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Performance Metrics January 2023 – July 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 973 KB, 23 pages

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Clinical Trials Performance Metrics: August 2022 - July 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 408 KB, 15 pages

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Clinical Trials Performance Metrics: July 2022 - June 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 403 KB, 14 pages

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Clinical Trials Performance Metrics: June 2022 - May 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 402 KB, 14 pages

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Performance Metrics January 2023 – June 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 503 KB, 22 pages

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Performance Metrics January 2023 – May 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 521 KB, 20 pages

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Performance Metrics January 2023 - April 2023: Assessment of New Marketing Authorisation Applications and Variations

PDF, 513 KB, 15 pages

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Performance Metrics May 2022 - April 2023: Assessment of Clinical Trial Authorisation Applications and Substantial Amendments

PDF, 383 KB, 14 pages

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Clinical Trials Performance Metrics: April 22 - March 23

PDF, 383 KB, 12 pages

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MHRA established medicines performance data - January to March 2023

PDF, 277 KB, 4 pages

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Details

In March 2025 the MHRA changed the way it provides performance data to expand our monthly reporting and give applicants clear insights into current expected processing times.

Please see MHRA Performance Data.

The information provided here will not be updated.

We publish routine updates to performance data for the assessment of clinical trials and established medicines within 15 days of the end of each month. This is to help improve the predictability of decision making in applications for clinical trials, marketing authorisations and variations to existing approvals. 

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