Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Advantages and disadvantages of the changes intended in the "Review 2001" with regard to Renewals of Marketing Authorisations and the impact on post-marketing surveillance ***
Miriam Hoffmann (Abschlußjahr: 2002)
In November 2001 the European Commission issued proposals for modifiying the existing European pharmaceutical legislation in order to meet the challenges of a continuous development in the pharmaceutical field and the enlargement of the European Union, while at the same time ensuring a high level of public health. The proposals are based on results of an evaluation of pharmaceutical legislation carried out by Cameron/ McKenna and Andersen. One of these proposals is the abolition of the 5-yearly renewal requirement for marketing authorisations of medicinal products and its replacement by stricter pharmacovigilance and post-authorisation rules.
The aim of this Master thesis is to discuss the advantages and disadvantages of this proposal and to consider the impact on the different parties involved (industry, authorities) and on the post-marketing surveillance system.
The evaluation of Cameron/ McKenna and Andersen revealed controversial points of view relating to renewals. There is strong support amongst companies for removing the burden of renewals, whereas regulatory authorities stated that the renewal process is useful because it enable to check a product´s safety profile based on new pharmacovigilance data and to re-assess the risk to benefit ratio on a regular basis, taking into account scientific and regulatory progress.
The renewal procedure is, according to the current pharmaceutical legislation, mainly focused on pharmacovigilance data and the re-assessment of the risk to benefit ratio.
As the marketing authorisation holder is legally obliged to check the quality, safety and efficacy of a medicinal product on an ongoing basis and notify any change of the properties of the marketing authorisation by using the variation procedures, the Commission concluded that the renewal procedure was a financial and administrative burden, time-consuming and resource-binding for both the industry and the regulatory authorities without adding to the protection of public health.
The abolition of the renewal requirement is considered to be appropriate if it will effectively be superseded by an improved and strong pharmacovigilance and post-authorisation system.
In addition to several past efforts to improve the pharmacovigilance rules, the Commission proposed to modify the PSUR cycle and to introduce the obligation to communicate reports of all suspected adverse reactions electronically, using harmonised data and reporting formats and internationally agreed medical terminology (MedDRA).
However, improvement of the pharmacovigilance system will depend on how the different European countries will implement the new provisions into their national legislation and on whether sufficient financial resources will be provided.
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