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EU Proposes To Chop EMA Committees, Drop Five-Year Renewals

The EMA, Not The Commission, Would Decide On Orphan Designation

 
• By Ian Schofield

The EU’s legislative revision proposals include stripping down the European Medicines Agency’s committee structure, abolishing the five-yearly marketing authorization renewal requirement, and doing away with the “sunset clause” that requires a product to be launched in at least one EU country within three years of approval.

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The EU has big plans in hand for medicines regulation • Source: Shutterstock

Among the many wide-ranging proposals for the overhaul of the EU medicines legislation that are due to be published at the end of this month is a radical restructuring at the European Medicines Agency that will see the number of its scientific committees reduced from six to two.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

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