NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

MHRA performance review. https://www.gov.uk/government/publications/medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-2021-to-2022/the-medicines-and-healthcare-products-regulatory-agency-annual-report-and-accounts-202122

Performance against targets
PM1
Area: Medicines licensing: validation of applications
Target description:

a) Type 1B and Type II variations - 97% of scientific validation process completed within 14 days of case creation

Target: 97% completed within 14 days
2021/22 (2020/21) total: 97.5% (100%)
Rating (RAG): Met
Target description:

b) New Marketing Authorisation applications - 97% of validation reports produced within 14 days of case creation

Target: 97% produced within 14 days
2021/22 (2020/21) total: 83.4% (91%)
Rating (RAG): Not met
Comments: Embedding Centrally Authorised Products (CAP) grandfathering transition activities resulted in backlogs in Q1 and a missed target. Performance was recovered in Q2 and returned to target in Q3-4.

Target description:
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a) The assessment of applications for New Active Substances (NAS) Marketing Authorisations for UK/GB - 97% assessed within 80 days (National including Orbis and Access Consortium)

Target: 97% assessed within 80 days
2021/22 (2020/21) total: 92% (100%)
Rating (RAG): Not met
Comments: This target was missed due to 3 assessments exceeding the 80-day limit. 1 NAS application was very complex due to the rarity of disease. This application was also affected by the prioritisation of assessment for antiviral products to treat COVID19. 2 other applications went marginally beyond the 80-day timeline because of scheduling issues and resource constraints. The new organisational structure will address the resourcing issues and this will be back on target by end Q2 2022/23.