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Another Indian CRO Under EMA Lens Over Dirty Data Concerns

 
• By Anju Ghangurde

Micro Therapeutic Research Labs is now under the scanner over alleged data integrity concerns. European Medicines Agency (EMA) is evaluating medicines based on studies done by the Indian firm.

Dirty hands

Indian contract research organizations continue to face regulatory scrutiny amid concerns over dirty data. The European Medicines Agency’s scientific committee, the CHMP, has now initiated a review of certain medicines for which studies were done by Micro Therapeutic Research Labs at its sites in Chennai and Coimbatore in India.

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More from Europe

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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