Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The new European Pharmacovigilance Legislation and its impact on the Generics Industry

Celine Lentrodt (Abschlußjahr: 2015)

Summary
Language: English
The new Pharmacovigilance Legislation is valid as of July 2012. It represents the most comprehensive adaption of the legal framework of human medicine since the introduction of the specific requirements of Pharmacovigilance in 1995. The European Pharmacovigilance system needs to ensure a high level of public health throughout the European Union. The new legislation strengthens the system to monitor the safety of medicinal products on the European market, which results in an improved safety for each patient due to better prevention, detection and assessment of adverse drug reactions.
Some of the new requirements resulting from the new Pharmacovigilance Legislation are improvements for the Generic Industry while others exacerbate the in general very regulated pharmaceutical environment in Europe.
One of the major goals of the new legislation is the increase of patient’s safety. But of course not all of the already implemented or still planned requirements have a direct impact on the patient´s safety. Some of them are intended to decrease the administrative effort for the industry and/or the authorities or to improve the organisation structure in Europe to enable an optimal information flow.
All in all, the replacement of the DPPS against the summary of pharmacovigilance system can be assessed as an improvement for the pharmaceutical industry in general. Avoiding the submission of all changes made in the DPPS as a variation and being able to introduce modifications in the PSMF without any regulatory impact is an improvement, which results in an advantage for the industry as well as the authorities.
In the field of the PSUR a great improvement is the publication of the EURD-list together with a PSUR exemption for many generic products. In the future it is worth to think about the possibility to exclude some “hybrid” applications (according to Article 10(3) of Directive 2001/83/EC) from the PSUR compulsory as well, in case they are probably authorised already for a long time or if their safety profile shows no significant concerns.
One of the major tasks with regard to Pharmacovigilance for the Generic industry is the adaption of the product information to remain in line with the reference medicinal product (Originator product). The Generic medicinal product has to stay in line with the product information of the reference medicinal product over the whole life cycle.
A huge simplification measure is the publication of national translations of the PRAC signals by the EMA starting February 2015. This is a great step towards more harmonized product information and an accelerated implementation of safety signals in Europe. Furthermore, this is a big relief for the Generic industry as well as the Innovator companies. It is much to be hoped that this approach will be extended to other assessments like PSURs or referral procedure.
Another step into this direction is the publication of the RMP summaries. To force the Generic industry to submit RMPs as part of all new applications might not be one of the most reasonable changes due to the fact that the medicinal products are already authorised eight years at the time of submission with a lot of post-authorisation experience. In the past, a huge problem for the Generic industry was the lack of public available information on the innovator´s RMP and additionally a not consistent assessment of the plans by the national authorities. At the moment regulatory authorities try to provide a list of safety concerns in their initial assessment report. The EMA plans to establish a peer-review mechanism to improve the review process and to standardize the resulting RMP. Probably a RMP single-assessment coordinate by the PRAC together with the publication of a core-RMP could be one solution to improve the harmonization of RMPs in Europe. Another problem in this context is the possibility that the reference medicinal product has no RMP or the product has an OTC ("over the counter") status, which normally results from a "safe" medicine.
The establishment of the Article 57 database has been finalized in 2014. From the financial and organisational perspective the xEVMPD was one of the main burdens for the Generic industry. The direct improvement for the industry cannot be estimated and might probably even remain quite small. However, to establish a European, and probably in the future even worldwide database, this task might be inevitable. With high probability the direct results from this sanction can be evaluated in the next five to probably ten years.
At the moment, the new fees regulation 658/2014/EC is one of the great unknown with regard to the Pharmacovigilance legislation. This regulation could result in a biggest burden for the Generic industry together with the implementation of the xEVMPD database.
For some changes, which seem probably redundant at the moment, the laurels can be gained only after years. An intense communication between the pharmaceutical industry and the European authorities has to be enforced and extended within the next years to establish a fully functional and helpful Pharmacovigilance environment in Europe for all concerned stakeholders – authorities, pharmaceutical industry, health care professionals and patients.
Pages: 57