Ian Schofield

A ruling by the Court of Justice of the EU has produced a clear definition of what constitutes the “first” marketing authorization when companies apply for SPCs on pharmaceutical products.

The EU Clinical Trials Regulation has “so far failed to improve Europe's competitiveness,” according to a new report commissioned by the pharmaceutical industry body EFPIA.

Olivér Várhelyi's plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.

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.

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.”

Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.

Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.

With approval applications for new active substances expected to rise by 25% by 2026, the UK regulator says it wants to focus its national assessment procedure on new innovative therapies. It will also review progress with the new International Recognition Procedure.

Companies are being encouraged to look at whether they will be impacted by new UK rules on supplementary protection certificates that come into effect from the beginning of next year.

The MHRA is taking steps to embed “meaningful and impactful” patient involvement across its regulatory pathways.