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.
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