Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Requirements in the European Union for Avian Vaccines: Impact of the "Guideline on Data Requirements for Immunological Veterinary Medicinal Products intended for Minor Use or Minor Species/Limited Markets" on Clinical Research

Dr. Petra Regenhard (Abschlußjahr: 2011)

Language: English

Poultry raised under commercial conditions are vulnerable to exposure to a number of pathogens. Disease prevention by vaccination is an integral part of health management in the poultry industry. In order to be placed on the market of an EU member state, avian vaccines as immunological veterinary medicinal products (IVMPs) must be granted a marketing authorisation by the competent authority of the corresponding member state in accordance with European Parliament and Council Directive 2001/82/EC as amended by directive 2004/28/EC and by directive 2009/9/EC, or an authorisation has to be granted in accordance with European Parliament and Council Regulation 726/2004/EC. The Committee for Medicinal Products for Veterinary Use prepares together with the competent authorities of the EU member states scientific guidelines to assist applicants in compiling marketing authorisation applications, and Annex I of Directive 2001/82/EC states in its introduction that applicants shall take into account these guidelines by assembling a dossier for an application for marketing authorisation. One of these guidelines for IVMPs is the "Guideline on Data Requirements for Immunological Veterinary Products intended for Minor Use or Minor Species" (EMEA/VMP/IWP/123243/06-Rev. 2). Veterinary medicinal products for minor use or minor species (MUMS) are the "orphans" of the animal health industry, there is only little interest under normal marketing conditions in developing and marketing such products. Reduced data requirements for clinical safety and efficacy studies for vaccine development are economic and regulatory incentives regarding cost reduction and saving time and resources. Free scientific advice will enable an applicant to put together an outline of the dossier and to ensure that the necessary information for an authorisation is in compliance with the possibilities for the reduction of data. But reality is that the likelihood of insufficient return on investment is the most significant disincentive to veterinary pharmaceutical industry to research and develop products for MUMS/limited markets. Despite the best intent, the increasing regulatory requirements result in higher research and development costs and force the unwillingness of the animal health industry to invest in products for MUMS/limited markets.

Pages: 40
Annex: 27 pages