Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Centralised Procedure from the Micro, Small and Medium-sized Enterprise's Perspective and Specific Obstacles of SMEs ***

Frank Zimmermann (Abschlußjahr: 2008)

Language: English

This thesis focuses on micro, small and medium-sized enterprises (SMEs) which perform centralised procedures to obtain European marketing authorisations for medicinal products.

Pharmaceutical SMEs suffer from a multitude of obstacles. In order to overcome these obstacles, the EC, as well as Member States, foster them in form of support programmes and administrative assistance. The SME status, as a prerequisite to benefit from such programmes and incentives, is based on the SME definition taking into account thresholds like staff headcount, turnover, and balance sheet total each on an annual basis, as well as qualitative standards like business relationships to other companies. All in all, the SME definition is well established and takes sufficiently into account the needs to foster pharmaceutical SMEs in consideration of existing SME subcategories and with regard to business relationships. The SME status application which has to be submitted to the EMEA is facilitated due to the use of the model declaration.
 
The CP is generally used for the marketing authorisation application of innovations and new human or veterinary medicinal products. In contrast, under certain conditions the CP may also be used for the marketing authorisation application of non-prescription products. But this proceeding is not fully sophisticated and will give rise to further discussions. However, the CP from the SMEs perspective is centred including topics, hurdles and incentives with significance for SMEs. Key aspects encompass, amongst others, dossier requirements, advice procedures, as well as specific procedures in accordance to Article 14 (7), Article 14 (8) and Article 14(9)/39(8) of Regulation (EC) No 726/2004, orphan drug designation, and e-submission.
Despite the difficulties and hurdles the CP enables SMEs to gain faster access to the single market and simultaneously to assure appropriate quality of the medicinal products due to the cooperation between the EMEA and national competent authorities.
 
Obstacles can be divided in financial, administrative and company-specific obstacles, as well as in specific hindrances for pharmaceutical SMEs. The impacts of the obstacles depend on the company size and available resources. In order to overcome these obstacles SMEs are supported by common support programmes at regional, national and Community level. In addition, pharmaceutical SMEs are also supported by specific financial incentives and fee reductions, as well as by procedure-related administrative assistance granted by the EMEA. Not all problems could be solved. Nevertheless, the described incentives are sufficient to ensure smooth marketing authorisation application submissions.

Pages: 51