Masterstudiengang "Drug Regulatory Affairs"


Pharma-Mittelstand - Drug Regulatory Affairs Portfoliostrategie ***

Petra Kist (Abschlußjahr: 2008)

Language: German

In Germany many small and medium-sized enterprises operate in the pharmaceutical sector. Several health care reforms since 2000 tighten the economic situation of these enterprises.

Instancing a fictitious family-owned and operated medium-sized enterprise the strategic management process illustrates different kind of portfolio strategies for the pharmaceutical industry. The conclusion of situation analysis, self-evaluation and competitor analysis, both internal and external, is that cost minimization strategies, product differentiation strategies, and market focus or market expansion strategies are the possible routes to adjust the portfolio to the changed economic situation.

A well-known plant based medicinal product of the fictitious enterprise is used to illustrate the market expansion strategy via a decision analysis. The different types of marketing authorisation applications according to Directive 2001/83/EC, as there are an Article 8(3) application (dossier with administrative, quality, pre-clinical and clinical data), an Article 10a well-established use application and an Article 16a traditional use registration, are checked against different regulatory and marketing/sales criteria.

Regulatory criteria are e.g. the necessary documentation in compliance with ICH-Guidelines, application expenses and the possibility to get marketing authorisations via MRP or DCP. An important criterion for a WEU and THMP application is the necessary time for which the substance has been medicinally used. The Marketing/sales criteria are e.g. reimbursement, advertising costs and sales expectancy.

A WEU application via DCP is the tentative choice of the described decision analysis. The regulatory criteria favour the registration as THMP because of lower regulatory requirements. However the application according to Article 8 (3) receives the lowest number of points, due to the highest regulatory requirements. Eventually the marketing/sales criteria lead to the alternative decision as WEU. The marketability of an OTC medicinal product depends on the phrasing of the indication. In simple terms major claims are appropriate for applications according Article 8 (3), medium claims for WEU applications and minor claims for THMP registrations. A medium claim in connection with manageable authorisation requirements, as given for this exemplary application, reaches a decision for the application as WEU.

Finally the risks of the tentative choice, the WEU application via DCP, are assessed by their probability and seriousness and preventive and contingency actions are established. All in all it is concluded that the WEU is the best balanced choice. The choice is supplemented by considerations on selecting the reference member state and the concerned member states.

Another focal point of this master thesis is the consideration of different possibilities to optimise the regulatory burden of medicinal product marketing authorisations in the EEA. An improvement of the regulatory burden is the withdrawing of non profitable marketing authorisations and the harmonisation of the remaining authorisations.

An Article 30 Referral according Regulation 2001/83/EC is described as a possibility to harmonise the marketing authorisations, granted through national procedures. Because of the high procedural fees and the high maintenance fees e.g. for variations through a MR-procedure the idea is abandoned by the fictitious enterprise.

A new helpful approach for the enterprise may be the European Commissions “Better Regulation” initiative to optimise, simplify and rationalise the regulatory processes, e.g. through a review of the Variations Regulations. The current state (until August 2008) of the new Variation Regulation is described.

Last - mentioned PSUR and renewal synchronisations in the EEA are considered to optimise the regulatory burden. Under the auspices of the “Heads of Medicines Agencies” an initiative has been taken to ensure that medicinal products containing the same active substance follow the same PSUR submission scheme in all EU Member States. This could increase the effectiveness of PSUR information by sharing the PSUR assessment workload throughout the EU. Connected with the PSUR synchronisation a harmonised and preponed respectively last renewal of marketing authorisations is described. These harmonisations possibilities will be used with immediate effect.

The outlook of this Master-Thesis is that an active product policy should be implemented in the next few years. It is inevitable that the Management Board, Marketing/Sales and Drug Regulatory Affairs have to work closely together to get marketable marketing authorisations. It is important to invest enough time in considerations of a registration strategy, the preparation of applications and the necessary documentation to get efficient marketing authorisations. Drug Regulatory Affairs, often seen as cost driver by the Management Board, should get more appreciation and support and should be involved in strategy decisions. Last but not least Marketing and Sales is able to work more efficient through the work of Drug Regulatory Affairs.

Pages: 80
Annexes: 8