RE: Sat 04 May 202410 May 2024 19:40
For China, yes, the reference product is Senstend, which is the marketing name for Fortacin - it’s the exact same product, just a different name for China. Therefore, it follows that the CMC documentation is exactly the same whether its Senstend or Fortacin so its completely wrong to say no CMC data exists. Genetic has the CMC data, including stability data for China which is 30 °C/65% RH at various time points starting at release, 3 months, 6 months, etc... And no MHRA authorisation has not expired – regulatory consultant filed in February 2024 with MHRA for the first 5-yearly renewal application for Senstend to MHRA. This should result in the GB MA being renewed for a period of unlimited validity (no further application would be required in a further 5 years).