An article from EFPIA reviews the current situation with Dynamic Regulatory Assessment (DRA). Not used for most routine MAA submissions, but rather for situations of promising treatments or emergency situations (e.g., pandemic). A DRA model proposed by EFPIA would use greater regulatory interactions, continuous knowledge building, data submissions at predetermined timepoints to achieve a faster approval - and doing so without compromising the level of evidence. Current IT technologies could support the approach but are not sufficiently robust to and may need to be specifically developed to make the use of DRA more routine. The EFPIA proposal for DRA is in line with EMA activities and proposed fee structures and is based on lessons learned from the development and approval of Covid-19 therapies.
Other considerations are in the brief article, as well as links to related information.
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