Europe

The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.

The results of a Phase III study did not confirm the benefits previously seen with Adakveo, the European Medicines Agency said.

Two new products, one for epilepsy and the other for prostate cancer, were recommended for EU approval during the latest monthly meeting of the European Medicines Agency’s human medicines committee, the CHMP.

The publication of two major reports has led the UK government to announce a £650m “Life Sci for Growth” package to bolster the life sciences sector.

The UK regulator, the MHRA, says that while it will recognize drug approvals granted in the EU and a selection of other countries, it will remain a “sovereign regulator” with the ability to reject applications if they don’t meet its standards.

The biobank, which the UK regulator believes puts it at the forefront of innovation in the field of drug safety monitoring, will enter a pilot in June, starting with the gout treatment allopurinol and related rare, severe skin reactions.

The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”

The European Medicines Agency’s human medicines committee, the CHMP, is meeting this week to discuss the EU marketing applications for a number of products that have reached the late stages of the regulatory review cycle.

Based on its learnings from proactively publishing clinical trial data on COVID-19 products, the European Medicines Agency is making procedural changes to its clinical data publication policy that is set to resume after being temporarily suspended in 2018.

New funding from the UK’s antimicrobial resistance innovation fund is to be welcomed, but the UK pharmaceutical industry body, the ABPI, has cautioned that “multiple global solutions” bringing together governments, health care systems and the industry are needed if research efforts are to result in effective new antibiotics.