The Medicines and Healthcare Products Regulatory Agency (MHRA) has reported its recent success in showing flexibility when needed to ensure a product was able to reach patients in a timely manner.
The product in question is a new influenza vaccine designed by Sanofi Pasteur for the over-65s. Following changes in legislation, a complex environment made approval of the new product something of a challenge for MHRA.
“Due to the desire to enhance its effect in older people, this higher dose formula has been optimised for the over-65 age group, resulting in a product which is more effective in older people than the standard flu vaccine.
“This meant that the changes needed to be thoroughly evaluated to ensure they did not change the safety profile of this vaccine compared to the well-established safety profile of other, more conventional flu vaccines.
“Whilst developing the product and preparing the regulatory submission, Sanofi Pasteur sought advice on scientific and regulatory aspects which were specific to its product.”
The Agency was able to adapt its timelines and coordinate its processes, completing the approval process in just seven months – a significant improvement over the usual twelve. In part, the Agency puts this down to the approval being national rather than international, so there were no inter-agency collaborations to consider when adapting timelines.
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