Pharmacovigilance outsourcing and contracting-out drug safety and regulatory activities can massively reduce expense and workload for any pharmaceutical marketing authorisation holder (MAH). However, overall responsibility and oversight of the pharmacovigilance system always remains with the MAH and the EU QPPV. Specifically, it is the responsibility of the MAH to correctly receive process and, where required, expedite reports of adverse events and other safety reports. Even where all pharmacovigilance activities are outsourced, the overall responsibility lies with the MAH. The legal and regulatory responsibility for any failure on the part of a pharmacovigilance outsourcing provider to correctly follow pharmacovigilance legislation lies with the MAH, not the company to whom pharmacovigilance has been outsourced.
The inbound flow and management of this safety information is governed by Safety Data Exchange Agreements (SDEA) and they are a legal requirement in all cases where safety data might be received by any third party – ie not the license holder.
The types of safety data received can be very varied, they can be reports of adverse events but equally they can be other safety data: reports of abuse, misuse, overdose, medication error, use in pregnancy, lack of efficacy – and others. The MAH has to have a system in place to receive these reports, the 3rd party must have processes in place to transmit these reports to the MAH and there must be an SDEA in place to control and guarantee that no safety data falls through any “gaps”. It is imperative that all the data gets through and there needs to be a system of acknowledgement of receipt and reconciliation of data sent and received.
The treatment of safety data varies somewhat between the US, EU and other areas, however in general the obligation to expedite safety reports of serious suspected adverse reactions to the competent authorities is at least similar across territories. The timeframe within which reports must be received begins when the report is received by the 3rd party subcontractor / outsourcing provider, NOT when the report reaches the MAH. Therefore it is in the interests of the MAH that reports are forwarded on to them (or to the service provider), to reach them as quickly as possible so that they may be processed properly and on time.
SDEAs will vary depending on the role being carried out by the 3rd party. If the third party is only carrying out sales activities their exposure to safety data may only require simple instructions on what to do if they encounter reports of issues. If the third party is more involved, a distributor, co-marketing company, co-developing company or licensee, the SDEA will be more detailed. Where the activity being outsourced is pharmacovigilance the SDEAs have to be more detailed still, since it is vital that all involved parties are aware of their responsibilities and processes with regards to safety reporting.
Depending on the relationship, the SDEA may have to include assignation of responsibility for EU QPPV, PSUR writing, literature searching, the submission of reports to regulatory authorities, answering regulatory authority questions, handling product complaints, signal detection, hosting the safety database and ongoing benefit-risk evaluation. If some or all pharmacovigilance activities are being outsourced, including Medical Information, Call Centres, Adverse Event Processing, the SDEA needs to be comprehensive, detailing which parties are responsible for which activities, even though the ultimate responsibility lies with the MAH. None of the above lists are exhaustive – the types of data and activities governed by SDEAs will differ from company to company and from product to product.
All of the SDEAs must be part of the MAH’s quality management system and the writing, approval and documentation of each SDEA and each type of SDEA must follow company SOPs and be auditable. This is a regulatory requirement and SDEAs are inspected during pharmacovigilance inspections and audits.
Yes. SDEAs can be requested for inspection under EU drug safety regulations and equivalent FDA legislation within the US. They must be produced within a certain timescale and within the EU they need to contain a specific list of key details, for example, details of the Qualified Person, etc. Our team construct robust, reliable agreements to ensure there is a mechanism whereby the correct data can reach the correct destination within a prescriptive and compliant timescale, ensuring that all activities occurring throughout the transit process are compliant with the regulations governing them. For a consultation on SDEAs, please contact the team in confidence on +44 (0)1483 307920; alternatively, you may prefer to email email@example.com
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Cooper T. Licensing arrangements – global regulatory framework. Pharmacovigilance Rev (2007) 1, 13-15
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