NorthWest Biotherapeutics Inc (NWBO)

[Magrit]

MHRA timelines

https://www.gmmh.nhs.uk/download.cfm?doc=docm93jijm4n2766.pdf&ver=4500

4.5. MHRA Review
Valid Clinical Trial Applications are assessed within 30 days of the receipt.
MHRA must provide a response within a total of 60 days from receipt of the original application (except for trials involving medicinal products for gene therapy, somatic cell therapy or medicinal products containing genetically modified organisms where the timeframe is 90 days). If further information is requested this should be sent to the MHRA within 14 days of the request so not to affect the 60 day timeline. All correspondence will be sent to the person named in Section C of the Clinical Trial Application form (i.e. the Chief Investigator (CI) or Sponsor’s representative) and should be filed on Q-Pulse (the Trial Master File) by the R&I Office.