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staggered situation. This has implications for conduct of studies to support pricing and reimbursement in individual countries and many of these will now have to be started at least during Phase III development. |
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The strategic impact of one dossier for Europe, one final assessment (at least in the centralized procedure), and one decision is therefore very high and obtaining a fast approval for applications with optimal labeling has to be a key goal for a pharmaceutical company. Consideration to strategic implications will need to be given through the drug development process, during the approval process, and postmarketing. This chapter is only dealing with the former two. |
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During drug development the following are some issues to be considered. |
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Contact must be developed with a potential Reference Member State country for the decentralized procedure. As the choice of country rests with the applicant it will be important to discuss the application with the selected country before filing to obtain their support. It may also be advisable to consult with one or a few countries during the drug's development (e.g., end Phase II) if there are issues that the company feels need clarification or advice; any differences in medical practice between countries should be identified and a strategy developed for ensuring this does not influence approval. Although clinical data are acceptable from all over Europe and from third countries, it may be advisable to consider having data available from the company's key European countries. |
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The choice of rapporteur for the centralized procedure is made by the CPMP but proposals by the applicant are taken into account, so again it will be important to have established the support of members of the CPMP during development. |
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Within the company decisions will have to be made at the appropriate time on the procedure to be used and, in the case of the decentralized procedure, the Reference Member Statemany factors may influence both decisions and will to an extent be both product and company specific. Some influencing factors are listed in Tables 3 and 4. In making these decisions, it will be important to build an in company procedure to ensure all interested parties, e.g., subsidiaries, are involved as the decision could have considerable business implications. In formulating a regulatory strategy an important factor will be the scope of the dossier, e.g., are all indications well supported? Given the nature of the procedures and the need for 15 countries to reach a consensus on the data presented, the regulatory strategy should seek to identify areas of possible weakness likely to cause discussion, queries, or dissension in the assessment and consequent delay in the process. In the initial years it will be vital to obtain information on the performance of the procedures for all applications in order to assist decision making on choice of procedure. This information may well |
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