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Focus on Regulation

Tag Archives: CHMP

Clinical trials: Digital technology for recruitment, consent, and data capture

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is transferred from the clinical trial sites (hospitals/HCPs) to the sponsor (i.e. pharma or device company) is transmitted in electronic form.

The European Medicines Agency issues an opinion on the principal mode of action of proanthocyanidins present in cranberry extracts

On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) concerning the principal mode of action of proanthocyanidins present in cranberry extracts and included in products intended to be used by their manufacturers for prevention and treatment of urinary tract infections.

The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues

Following its adoption by the Committee for Medicinal Products for Human Use (“CHMP”) on 18 December 2014, the European Medicines Agency (“EMA”) recently published a finalised version of its Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (hereafter “EMA Guideline”). The revised EMA Guideline is expected to come into force in July 2015 and will replace the current guideline which came into effect in June 2006.

CHMP Adopts New Guidelines on the Treatment of IBS

On 25 September 2014, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted new guidelines on the evaluation of medicinal products for the treatment of irritable bowel syndrome (“IBS”) (the “New Guidelines”). The New Guidelines will come into effect on 1 April 2015.