EU pharmacovigilance laws mean that ALL spontaneous reports regarding serious adverse reactions must be expedited within 15 days.In addition, from 22nd November 2017 all non-serious adverse reaction ,with an origin within the EU, will require expediting to EMA within 90 days.
These laws will mean that ALL suspected reactions provoked by a medicinal product must be expedited – regardless of seriousness.
One of the most common causes of critical findings in Drug Safety Inspections is the non-compliance with the expedited reporting of spontaneous adverse drug reactions
Non-compliance can result in time-consuming and costly remedial work and/or penalties imposed by regulators. These can include inspections, CAPAs and suspensions of Marketing Authorisations.
In the EU post-marketing environment, an Individual Case Safety Report (ICSR) may involve a serious or non-serious adverse reaction – regardless of expectedness. Such cases must be submitted to the regulatory authorities within 15 days or 90 days respectively. As a Marketing Authorisation Holder, you need to be fully versed in each change to the drug safety laws in concerned territories around expedited reporting as and when it happens. Including the responses you need to introduce to remain fully compliant. With the right support you can rapidly respond to the challenges in line with your Standard Operating Procedures.
Any clinical trials including post authorisation studies during the post marketing phase of a product will need to be correctly processed and expedited according to regulatory requirements.
PrimeVigilance drug safety services consultants place particular emphasis on the timely reporting of post-authorisation case reports. With a fully validated E2B compliant safety database (ARISg™), highly effective SOPs and operating guidelines, thorough employee training and a constant quality management system ‘on time’ reporting is a major priority. Reports may be made electronically or by hard copy as required by local regulations. PrimeVigilance may register and run electronic reporting systems such as EudraVigilance. EMEA trained employees to ensure compliance with the rigorous requirements’ of such a system.
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