Latest from Ian Schofield
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.
Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
The COSIsiFA initiative includes a new independent website, regular newsletters, a six-monthly bulletin, and training courses to help promote the appropriate use of medicines.
Olivér Várhelyi’s plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.