Europe

The EMA received more than 1,000 responses to its draft reflection paper on AI in drug development, some of which will be incorporated into the final document, an agency representative told this week’s RAPS Euro Convergence 2024.

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After several rejections by NICE and an appeal by Pfizer, the company has reduced the price for its first-in-class sickle cell disease drug to a level that the health technology assessment institute deems acceptable.

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Developing drugs for some rare diseases is “just not commercially feasible,” meaning that alternative approaches, such as funding through venture philanthropy and not-for-profit models, need to be explored, a gene therapy professor has said.

The European Parliament has voted for a deal agreed with the council of minister to ensure polluters pay for cleaning up urban wastewater.

Shionogi’s UK general manager praised NHS England’s novel subscription model for antibiotics, but warned the country would be “wasting money” unless other global regulators introduced similar incentives for antimicrobial development.

The European Medicines Agency has published guidance on how to strengthen the supply chain for products included on the EU’s critical medicines list.

The bill on new rules on companies holding minimum stock levels for “critical medicines” has been amended but is still likely to take effect at the beginning of July.

The UK regulator says it wants to come an ‘enabler’ of clinical trials by helping sponsors to deal with potential problems earlier on in the process. 

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 MHRA’s regulatory strategy on AI outlines key areas where this technology could be used to improve the agency’s own processes, and says that the use of AI to develop drugs will not change the questions it asks companies.

Work on safeguarding the medicine supply chain should be accompanied by ambitious actions to ensure the future of the sector, including a new deal on competitiveness, says the pharmaceutical industry.

While the UK’s drug regulator, the MHRA, has “pulled its socks up massively” in recent months, its poor performance was highlighted as a top cause of the UK’s faltering clinical trials ecosystem by a former health minister.

Variant vaccine approvals can be based on manufacturing/quality and non-clinical data as long as data on earlier vaccines support the predictability of clinical immunogenicity and reactogenicity.

The European Medicines Agency is looking to increase the review efficiency and consistency of its assessors by experimenting with a US FDA-style approach in which companies can voluntarily submit certain information in advance to facilitate the product’s review.