The European Medicines Agency has unearthed a ‘sartan’ medication, in losartan, that contains low levels of the carcinogenic substance, N-nitrosodiethylamine.
Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
It has been revealed that the EMA is awarding significantly fewer contracts to evaluate the application of new drugs to the MHRA, as the Brexit deadline nears.
The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.
The Chinese government has released a notice telling medical institutes to comply with the recall of products containing contaminated valsartan and stop using the medicine.
Pan-American countries should adopt EMA-style regulations to increase clinical trial transparency and streamline research, according to a recent report.
The US FDA has joined other national regulatory bodies across the globe in recalling certain valsartan medicines, which were found to contain a probable carcinogen.
An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
BioIVT adds transporter assay products and services to its ADME-Toxicology portfolio with the acquisition of Optivia Biotechnology – a deal which aligns with the company’s efforts to support drug safety and efficacy, says VP.
Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation
The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.
The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.
As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved, the agency is still implementing a number of the individual modules that make up the over-arching law.
EFPIA (European Federation of Pharmaceutical Industries and Associations) and EGA (European Generics Association) have released comments suggesting specific changes to the EMA’s draft guidance on stability data for manufacturing changes.
The European Medicines Agency (EMA) has abandoned plans to stop researchers downloading clinical trial data but the European Ombudsman says she is unaware if other limits on transparency remain.
Transparency campaigners have called on the EMA (European Medicines Agency) to rethink regulations set to be approved on Thursday that they say will severely limit clinical trial openness.
In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.
The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.
Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).