The European medicines regulator has put in place the necessary arrangements to begin watching the Project Orbis process imminently but has maintained its stance that the initiative focuses only on the “magic moment” of a drug approval.
The Project Orbis initiative, an international regulatory collaboration led by the US Food and Drug Administration, could soon welcome the European Medicines Agency as an observer.
The EMA’s intention to watch the Orbis process more closely was announced in June 2023, but little was revealed about the
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
