Hello,
We also were experiencing extreme delays in getting communication from MHRA this fall/winter, and similar to your experience, we were not receiving a timeline or any information as to our request. This wasn't even for a CTA submission, just a standard communication requesting information from the agency, and it took over 2 months to get ANY response. Eventually, I emailed AND called the Clinical Trial Helpline directly to get information. I was told that our reviewer was on annual leave.
You might consider reaching out to the clinical trial helpline.
I'd also like to check in with the community on a possible strategy. The regulators are, of course, all under extreme backlogs, but given these extreme timeline extensions with no communication, what is the collective thoughts on reminding agencies of the timelines laid out in their regulations and guidelines? For example, in the UK, pursuant to the MHCTR 2004, Part 3, Sections 18, 19, or 20 (depending on the situation), item 3 states that if the agency doesn't provide a written notice to the sponsor within 30 days of the date of receipt of a valid request (item 2 of the same section), that the trial is to be treated as authorised:
Authorisation procedure for clinical trials involving general medicinal products 18.-
(1) This regulation applies to clinical trials involving medicinal products other than those to which regulations 19 and 20 apply.
(2) The licensing authority may, within the period of 30 days from the date of receipt of a valid request for authorisation of a clinical trial to which this regulation applies, give written notice to the sponsor-
(a) setting out the licensing authority's grounds for not accepting the request;
(b) stating that the licensing authority accepts the request for authorisation; or
(c) stating that the licensing authority accepts the request for authorisation, subject to the conditions specified in the notice.
(3) Subject to paragraph (4), if-
(a) a notice is given in accordance with paragraph (2)(b); or
(b) no notice is given in accordance with paragraph (2),
the clinical trial is to be treated as authorised.
Source: https://www.legislation.gov.uk/uksi/2004/1031/pdfs/uksi_20041031_en.pdf, page 19.
I'd be interested in hearing what others think.
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Ashley Butler
Associate Director, Regulatory Operations
Cambridge MA
United States
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Original Message:
Sent: 06-Apr-2023 12:10
From: Anonymous Member
Subject: MHRA CTA Application delays?
This message was posted by a user wishing to remain anonymous
Hello
I'm wondering if people would be willing to share anonymously any recent experience with filing a CTA with the MHRA and delays you are experiencing? My experience is that we filed a CTA in October and have still not heard from the MHRA. We are working with a representative within the UK who submitted the application and interfaces for us, and they have said they are experiencing this delay across all of their clients. They are emailing every few weeks and getting standard responses just saying there is a backlog and MHRA provides no expected timeline. If this wasn't so awful it would be almost comical how late this is. I'm just wondering if anyone else is experiencing this, and perhaps had luck getting through to MHRA via another pathway aside from email? Thank you.