In another of the many guidances it has issued on medicines regulation in the post-Brexit UK, the MHRA explains the additional information it will need from companies whose EU marketing authorizations are converted into national MAs in January 2021, and the new labeling requirements for those products.
Updated guidance issued by the UK regulator, the MHRA, explains the “essential baseline data” that pharmaceutical companies will have to provide for products with EU centralized approvals that are converted into Great Britain marketing authorizations at the beginning of next year.
The data will need to be submitted within a one-year period starting on 1 January 2021, through a new “national...
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.
