Freedom of Information request on the number of 150-day applications have been submitted (FOI 22/467)
Published 27 March 2023
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FOI 22/467
16th May 2022
Dear
Thank you for your request which has been handled under FOI Act 2000. Apologies for the delay that you encountered whilst we processed your request.
We confirm that we hold the requested information. However, because a period was not defined in your request, we have selected that which commenced from the beginning previous year.
We confirm that 47 new active substance applications have been received since 1st January 2021. Of these applications 18 have been granted, 13 of which were granted within 150 days.
We would like to highlight that we consider a major factor in the in the time taken to approve to relate to the frequency of low-quality submissions. Low-quality submissions consume assessment time due to three main factors:
- The time taken to locate the relevant information in the dossier and then to identify and describe any issues/concerns in our requests for information (RFIs).
- Assessment reports drafted on low quality submissions, are known to take a great deal more time and resource versus that required for high-quality submissions.
- Low quality submissions are more likely to require the detailed attention of the CHM, and additional work and processes needed.
If you have a query about the information provided, please reply to this email.
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre