Replies to post #761440 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

For a Marketing Authorisation Application (MAA) involving a New Active Substance (NAS) under the UK’s national assessment procedure, the Medicines and Healthcare products Regulatory Agency (MHRA) typically issues one Request for Further Information (RFI) during the evaluation process. This RFI is generally issued around Day 90 of the assessment timeline. Applicants are expected to respond promptly to facilitate the continuation of the review process. ? ? ?

In certain circumstances, if the initial response does not fully address the MHRA’s concerns, a second RFI may be issued. However, the issuance of a second RFI is not guaranteed and depends on the specific issues identified during the assessment. If significant concerns persist after the second RFI, the application may be referred to the Commission on Human Medicines (CHM) for further consideration. ?

It’s important to note that for applications concerning established medicines (i.e., those not classified as innovative), the MHRA has streamlined the process by limiting the evaluation to a single RFI. This approach aims to expedite the assessment and decision-making process for such applications. ?

For the most accurate and up-to-date information regarding RFIs and the assessment process, applicants are encouraged to consult the MHRA’s official guidance or contact the agency directly.

[exwannabe]

If I remember right , MHRA guidelines said that they only issue at the most two official RFIs . But they can unofficially of course ask for more info.

There is clearly a disconnect between the guidance (what MHRA says they should do) and the statute (what the Government is telling them to do). Clearly they have failed to meet their own guidance.

The law says they can stop the clock whenever.

Also, that recent guidances you are noting has bumped the 60 days to 6 months:

2.4 Responses assessment phase until Day 150
You must respond to all questions raised in the first RFI within 6 months, but we encourage you to submit your complete responses as soon as possible. If you do not submit a complete response within 6 months, we will notify you that we propose to refuse your application. In exceptional cases, we may agree to extend the clock-stop period beyond 6 months.