EU Commits To Flexibility On EPI
EU Regulators Adopt Key Principles On Electronic Product Information
EU regulators have adopted key principles for using electronic product information for human medicines, which are now expected to be followed by all parties involved in developing and implementing ePI.
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The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.
A multi-stakeholder workshop this month is expected to result in draft EU proposals on how to start disseminating product information in electronic formats.
The international group of pharmaceutical inspectorates, PIC/S, has issued an aide-memoire and a Q&A document to support its 2018 guideline on using health-based exposure limits to assess the risk of cross contamination in shared manufacturing facilities.