Pharmacovigilance: MA holder responsibilities beyond authorisation
The responsibilities and obligations of MA holders of human medicines are not limited to the marketing authorisation; on the contrary, they continue for the whole life of the product. Only operations and tasks change.
The release of a MA opens to the world of pharmacovigilance, i.e. all those operations to be carried out by the MA holder that contribute to public health protection.
In particular, the goal of pharmacovigilance is to ensure a positive risk/benefit profile for the population by identifying, assessing, understanding and preventing any adverse event or any other issue related to the use of medicinal products.
Sources to monitor
The sources of possible adverse reactions that need monitoring are multiple and include spontaneous reporting by consumers or health professionals, clinical trials, scientific literature, quality defects, reports from partners in other countries.
Although a drug undergoes clinical trials before being marketed, as required for the release of the marketing authorisation, this post-marketing control is essential.
In fact, these are generally carried out on a population that is relatively small and for a limited period of time.
Instead, pharmacovigilance allows a wider view since in the post-marketing period the medicinal product is used on a large scale, in greater and more heterogeneous populations and for a longer period.
EU QPPV, the contact person
The contact person for pharmacovigilance is the EU QPPV, that is the European Qualified Person for Pharmacovigilance, accompanied by their deputy in order to ensure the continuous control and the management of all activities.
Envisaging all the activities to be performed for each medicinal product, it is clear that the workload for pharmaceutical companies is rather considerable.
However, although the final responsibility is the MA holder’s, pharmacovigilance activities can be outsourced to specialised consultants taking care of all activities in full.
It is in fact common for pharmaceutical companies to entrust consultants capable to manage the pharmacovigilance of their products, taking on also the role of EU QPPV, in order to meet all legal requirements.
Quality controls
Along with the activities related to the management of reports, carried out by the EU QPPV and all the involved staff, an important section of pharmacovigilance is the quality unit. This takes care of managing all documents, procedures, conformities, audits and agreements, in order to ensure that all activities are performed according to the quality standards.
This section is essential for the appropriate functioning of the whole pharmacovigilance, and also manages the audits (carried out to, and received from, the various partners) as well as the inspections performed by Competent authorities.
Audit management
According to the regulations, each MA holder must qualify their own suppliers, and this requires audits to be carried out to the partners they cooperate with.
These collaborations can be several, as they include distributors, sale concessionaires, manufacturers as well as companies performing the role of Local contact Point (LCP) in other European countries, partners that are MA holders in the RMS o in the CMSs, based on the authorisation procedures of the product, and even extra-European companies in the case of registrations outside the European Union.
Managing audits is a wide and complex activity, including a preliminary preparation for the assessment of documents, usually taking at least a whole day to audit the involved partner, followed by the drafting of a report including any non-conformities (NCs) to be followed up until they are solved.
Inspections by the Competent Authorities should also be considered, i.e. by AIFA in the case of Italy.
In this case, the commitment is greater as Authorities analyse in details the whole pharmacovigilance system of the company as well as their interaction with any consultant.
Typically, non-conformities are always detected, as experience and professionalism allow officers to highlight more or less relevant deficiencies in the company pharmacovigilance system.
Supporting pharmacovigilance from the outside
Entrusting an external consultant with the management of pharmacovigilance with expertise in this matter is therefore a winning move for pharmaceutical companies that can see their workload in this sector considerably reduced.
The outsourced consultant will bear the whole workload; while the company is only requested to take part to some operations, but to a very limited extent.
Di Renzo Regulatory Affairs offer a full pharmacovigilance management. With their experience and expertise, their team is able to take on the role of EU QPPV/Deputy EU QPPV, LCP, but also to take care of only some of the activities based on the specific needs of the company. Moreover, the pharmacovigilance quality unit of Di Renzo Regulatory Affairs can carry out audits and is therefore available to perform this single service.
