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EMA Clarifies Compliance With ALCOA Principles Is Key To Meeting Data Integrity Expectations

 
• By Vibha Sharma

The EMA's guidance on data integrity expectations focuses on good manufacturing practice requirements and offers advice on minimizing risks at all stages of the data lifecycle in pharmaceutical quality systems.

The European Medicines Agency has issued new guidance to help ensure the integrity of data generated while testing, manufacturing, packaging, distributing and monitoring medicines.

As data integrity is a "significant topic" for industry and the regulators alike, it's helpful to have further clarification on...

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More from Europe

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 
• By Francesca Bruce

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

EMA Backs 14 New Drugs, Confirms Atropine Rejection For Myopia

 
• By Vibha Sharma

The European Medicines Agency’s human medicines committee has recommended 14 new drugs for marketing approval, including treatments for RSV, menopause, diabetes, and generalized myasthenia gravis.

Speed, Reach And Impact: New Metrics To Drive EU Clinical Trials Reform

 
• By Vibha Sharma

Clinical trials in the EU will be measured against new benchmarks from 2026 to identify how the bloc’s clinical research environment compares with that of other regions, and to identify areas for improvement.

EU-Level Efforts To Mitigate Drug Shortages Unsuccessful, Audit Reveals

 
• By Eliza Slawther

Actions taken by the European Commission and European Medicines Agency to tackle critical shortages of medicines have not succeeded in practice and further systemic improvements are required to address supply issues, a report from the European Court of Auditors has found.

More from Geography

Belgium Competition Authority Tackles Reimbursement Barriers For Combination Drugs

 
• By Francesca Bruce

The Belgian Competition Authority has set out guidance on how pharmaceutical companies can share information on combination therapies when seeking their reimbursement.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 
• By Sarah Karlin-Smith

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.