The participation in the European Pharmacovigilance Congress 2018 in Milan, of which we were the main sponsor, gave us the opportunity to perceive the moods of the pharmaceutical industry operators one year after the new pharmacovigilance rules entry into force. Here are the main considerations:
The mood of the sector one year after the entry into force of the ICH R3.
The new legislation follows logic that aims at a greater collaboration in the surveillance of drugs between Market Authorization Holders, Sponsors of clinical studies and Agencies.
However, the result is that all the stakeholders undergone an increase in workload.
An activity that involves the MAHs is linked to the collaboration with EMA for the reduction in EudraVigilance of the duplicates related to their product. The purpose is to obtain more reliable evaluation of safety signal. As consequences, new business processes derived, but in some circumstances, the efforts put into place give the perception that the new modus operandi has not achieved an effective reduction, but rather a potential increase of duplicates. In fact, the concern of receiving findings during pharmacovigilance inspections has led pharmaceutical companies to generate an unjustified excess of imports into the company safety database, even when not necessary. In addition, an over-reporting to EMA has been created with a consequent growth in the number of duplicates, as it happens for the cases downloaded from EudraVigilance by a MAH and retransmitted to EMA by the same MAH, even in the absence of follow-up information.
It was then clarified that there is no obligation to import into the company database all the cases identified in EudraVigilance as their own, but only those reported by the National Competent Authorities. Those reported by other MAHs, for example, are excluded. The MAH has to demonstrate, through the appropriate tools, that the non-imported cases have been included for the signal detection as well.
It was also understood that it is necessary to retransmit the cases downloaded from EudraVigilance, only in presence of follow-up with relevant information.
The difficulties, the improvements and the new needs that involved pharmacovigilance team.
At the time of implementation of the new R3 there were several doubts about how to perform the new activities emerged.
A job that required a great effort is that related to electronic transmission. The companies that use the gateway had to face the complex testing activities with EMA and consequently define the protocols for testing and validating the data exchanges with the Agency. Moreover, the same files made available by EMA presented problems that initially the Agency ignored. In the following months it was necessary to repeat the tests several times and each time to redefine protocols and procedures. On the other hand, it is not easy even for the pharmaceutical companies that use the Web Trader. If it is true that, in the work-load, EMA accepts the old R2 format, the companies still have the task of converting it into R3 format, implementing a series of check procedures to search the missing data, to correct and to manually complete them before the final transmission to EudraVigilance.
After the release the need to make corrections to the system immediately emerged. EMA intervened with dozens of adjustments that meant onerous efforts for the companies forced to readjust the internal processes.
To give another example, among the improvements made by the new regulations, it has to be recognized that the second release of the GVP – module V – Risk Management System shed light on the choice of the modules to be used according to the type of product.
What a pharmaceutical company expects from a good pharmacovigilance software.
All companies need to make their processes more efficient and effective by reducing efforts, resources and therefore costs. A pharmacovigilance software should first of all lighten the workload of the operators and save them from the intermediate check on the data population correctness in EudraVigilance.
It should also support and facilitate the verification of EudraVigilance outputs and the comparison with the company ones to ensure a complete and reliable signal detection.