1. Pink Sheet
  2. >>Product Reviews
  3. >>EU CHMP

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EU CHMP Opinions and MAA Updates
• Source: Pink Sheet/Shutterstock

The European Medicines Agency’s key scientific panel, the Committee for Medicinal Products for Human Use (CHMP), meets once a month and among other things adopts positive or negative opinions on EU marketing authorization applications (MAAs) filed through the centralized procedure for new molecular entities (NMEs), biosimilars and generic medicines. CHMP opinions are sent to the European Commission, which makes a final, legally binding decision, usually within 67 days.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from EU CHMP

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 
• By Francesca Bruce

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

More from Approvals

New EU Filings

 
• By Neena Brizmohun

Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Japan Recommends Beyonttra, Raises Enhertu Price

 
• By Lisa Takagi

Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

Generic Approvals Maintained Pace In December And January, But Is A Slow-Down Coming?

 
• By Derrick Gingery

Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.