According to Medical Devices Regulation and In Vitro Diagnostic Medical Devices, Notified Bodies have to establish lists of their standard fees for conformity assessment activities and make them available to the public.
While the pharmaceutical industry will be as affected as any other by the new Regulation on EU packaging and packaging waste, it would also enjoy some limited exemptions under the current proposals.
Several European regulators provide perspective on the use of mechanistic models in a complex generic drug development.
AI has the potential to greatly impact the regulatory affairs industry by helping with decision-making, detecting deficiencies in documentation, and automating tasks such as document generation and regulatory updates. It can also be used in collaboration with other companies and manufacturers to improve work efficiency and gain insights into drug content and public perception.
Today, the European Commission has proposed an extension of the transition period to certify medical devices.