Archive for December 2016

The European Medicines Agency adopted a final guideline setting out the information required for the evaluation of active chemical substances used in drug products. Source: International Pharmaceutical Regulatory Monitor

The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Source: International Pharmaceutical Regulatory Monitor

Drugmakers have expressed concern about the German government’s proposal to restrict drug pricing — contending that the measure penalizes research and development. Source: International Pharmaceutical Regulatory Monitor

The European Medicines Agency published new guidance on whether less comprehensive data can be used to support a new indication for a previously approved orphan drug product. Source: International Pharmaceutical Regulatory Monitor

Indian drug regulators in seven states have accused 18 drugmakers of selling substandard therapies after quality tests identified a range of product issues ranging from deceptive labeling to inappropriate quantities of active ingredients. Source: International Pharmaceutical Regulatory Monitor

Three years after issuing proposed guidance that laid out the FDA’s expectations for quality agreements with contract manufacturers, the agency has firmed up and expanded what sponsors must do to ensure that their agreements with CMOs are clear and enforceable. Source: International Pharmaceutical Regulatory Monitor

As part of its clinical trial data auditing initiative, the Chinese Food and Drug Administration verified data from an initial set of 55 clinical trials, focusing mainly on large, international drugmakers. Source: International Pharmaceutical Regulatory Monitor

The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018. Source: International Pharmaceutical Regulatory Monitor

Japanese drugmaker Sekisui Medical Co., Ltd has received a warning letter after an inspection in June revealed significant data integrity issues. Source: International Pharmaceutical Regulatory Monitor

The International Council for Harmonisation adopted an update to its good clinical practice guideline, recommending approaches to clinical trial design and management, as well as ensuring patient protection and data integrity. The amendment to its E6 guideline will now be implemented by ICH members through national and regional guidance. Source: International Pharmaceutical Regulatory Monitor