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New Pharmacovigilance Legislation July 2012
The deadline for implementing the new pharmacovigilance legislation within the EU ended on 21 July 2012. The new pharmacovigilance system is tailored towards improving public health within the EU, with the implementation of new legislative changes being mandatory for both small and large companies alike.
The framework of the new legislation is formulated from EU regulatory requirements Regulation 1235/2010 and Directive 2010/84/EU. In addition, the EMA has replaced Volume 9A of ‘The rules governing medicinal products in the European Union – Pharmacovigilance’ with the good pharmacovigilance practice guidelines (GVP) which is comprised of 16 modules, 11 of which are now completed and the remaining 5 are expected to be made available by end 2013.
The new legislative changes have altered the way in which pharmacovigilance systems are managed from the ground upwards. For instance, the Pharmacovigilance system master files (PSMF) replaces the Detailed Description of Pharmacovigilance (DDPS), the location of which must be registered with Eudravigilance and must accompany any new licence application or renewals submitted by the MAH.
In addition, both the format of the PSUR (renamed the Periodic Benefit Risk Evaluation Report or PBRER) and the PSUR submission timeframes have been substantially altered. On the plus side, PSUR reporting for ‘lower risk, well-established’ products are now no longer obligatory, however , if authorities believe reports may be of benefit towards public health within the EU, reports may once again become mandatory.
The new changes have increased the importance of pharmacovigilance services more than ever, with the new PSUR format requiring discussion and oversight of a company’s annual signal detection activities and the inclusion of pre-clinical and clinical study data. To remain compliant with the legislation will require strong collaboration between various departments within a pharmaceutical company, many of whom have no real grasp of how big the new legislative overhaul has been.
The impacts on pharmacovigilance have huge implications and are resource intensive. The mandatory requirement to report all non-serious cases, and the expansion of legislation to monitor a broader case remit such as off-label use and occupational exposure, show a major shift in focus from safety reporting to on-going risk assessment.
Many companies are still struggling to get to grips with the new guidance. At Red Line we have implemented the new guidance and are fully prepared to help the pharmaceutical industry remain compliant with the new legislation. We can assist clients to ensure these changes are implemented in a manner which is relevant to the specific needs of their business.
Professional enquiry handling to support the safe and effective use of your products.
Ease the regulatory burden and keep compliant with current pharmacovigilance legislation.
Product safety through surveillance of published articles and case reports.
Confident staff to support the pharmacovigilance process.
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