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Sunday, April 07, 2024 8:37:01 AM
For COVID-19 vaccines, regulatory processes were expedited to make vaccines available as quickly as possible to respond to the public health emergency. Since then, they have reformed and decided to broadly apply the new expedited regime. However, this expediting regime was never meant bypassing the MHRA or the CHM. In fact, amendments were made to the Human Medicines Regulations in 2012 to allow for temporary authorisation of an unlicensed product in response to a public health threat, but only if specific conditions of safety, quality, and efficacy set out by the MHRA were met. The MHRA, with advice from the CHM, was still responsible for reviewing and granting temporary authorisation for COVID-19 vaccines, ensuring that they met stringent standards through a comprehensive clinical trial program .
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