Remaining compliant throughout all the changes to EU legislation can be a challenging endeavor for any company. This is particularly the case with Expedited Reporting – one of the pillars of all EU pharmacovigilance work.
EU pharmacovigilance laws mean that ALL spontaneous reports regarding serious adverse reactions must be expedited within 15 days. In addition, as of 22nd November 2017allnon-serious adverse reactions, with an origin within the EU, 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 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.
What Is Expedited Reporting?
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. With regards to these updates, you as the Marketing Authorisation Holder need to implement them 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-authorization studies during the post-marketing phase of a product will need to be correctly processed and expedited according to regulatory requirements.
Why Choose PrimeVigilance For Your Expedited Reporting?
PrimeVigilance drug safety services consultants place particular emphasis on the timely reporting of post-authorization case reports. With a choice of fully validated E2B compliant safety database solutions (Argus Oracle Health Sciences Safety), highly effective SOPs and operating guidelines in place, 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. Our EMEA-trained employees are there to ensure compliance with the rigorous requirements of such a system.