The European Medicines Agency (EMA) has published a draft qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The draft Opinion was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP). It presents CHMP’s views on the “regulatory acceptability” of eSource
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.
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.
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.
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.