Patient Groups Back EU Cross Border Clinical Trials Access Initiative
An EU project for framing recommendations and best practices to improve cross-border access to clinical trials is gathering pace.
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High Ambitions For EU DARWIN Platform After Delivery Of First RWE Studies
Within one year of its establishment, DARWIN EU has started reaping benefits for EU drug regulators commissioning studies using real-world data to better understand diseases, populations and the uses and effects of medicines. The studies can be performed faster, cheaper and at increased capacity.
WHO Consults On Updates To 24-Year-Old GMP Requirements For Pharma Excipients
The World Health Organization wants to update its guideline on manufacturing pharmaceutical excipients to ensure these products meet the requirements for quality and purity that they purport or are represented to possess.
European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation
The commission is in talks with EU member states to identify possible regulatory bottlenecks in the approval of combined clinical trials for a medicinal product and a clinical performance study of an IVD.