Masterarbeit
Comparison of marketing authorisations procedures for biotechnological products in the European Union and in Switzerland ***
Katrin Dürr (2005)
Language: English
Due to its political situation of not being a member of the European Union or the European Free Trade Area, Switzerland has an independent legal framework for Marketing Authorisation and supervision of medicinal products. With the reorganisation of its regulatory framework in the beginning of 2002, Switzerland has aimed to bring the existing provisions in line with European law and Mutual Recognition Agreements with third countries. In 2004, major changes were introduced to the legal framework in the European Union with the adoption of the revision of the pharmaceutical legislation, with most of its provisions coming into force in November 2005. In June 2005, the Swiss Agency for Therapeutic Products published a new package of ordinances for comment, which includes new provisions for medicinal products indicated for serious and life-threatening diseases for orphan medicinal products.
The aim of this master thesis is to investigate similarities and differences of Marketing Authorisation procedures for medicinal products in the European Union and in Switzerland, paying particular attention to the recent developments, and to provide an overview of current legislation for internationally operating companies wishing to obtain approval in Switzerland as well as for Swiss subsidiaries aiming to understand current European processes. To narrow the discussion to innovative medicinal products, the comparison is limited to Marketing Authorisation procedures for the product group of biotechnologically derived medicinal products, which have produced breakthroughs in the treatment of serious diseases including cancers, neurological disorders, diabetes, multiple sclerosis, enzyme deficiency diseases and arthritis.
The current regulatory framework is compared with respect to the provisions for standard Marketing Authorisation procedures for biotechnologically derived medicinal products and is also analysed for its possibilities to accelerate the assessment procedure and to make innovative, therapeutically needed medicinal products available to patients as soon as possible. Additionally, as an outlook, current legal pathways for approving similar biological products (biosimilars) are investigated.
In summary, standard Marketing Authorisation procedures for biotechnologically derived medicinal products are comparable in actual assessment times, not including clock-stops. A clear difference can however be observed in the possibility of meetings and oral hearings before or during the assessment procedure, the course of the assessment procedure and the time-point for provision of additional data after the Marketing Authorisation application. With respect to the possibility of accelerating the assessment procedure, the basic concepts will essentially be comparable in the European Union and in Switzerland after coming into force of the remaining provisions of the revised European legislation and the new package of ordinances in Switzerland. However, differences like access criteria for procedures, the course of procedures and the time frames needed for assessment, are still an obstacle for internationally operating companies aiming to obtain approval for innovative medicinal products within short time. A greater grade of harmonisation of Swiss provisions to European legislation is therefore welcomed, which could also facilitate stronger collaboration and exchange of assessment results between European Regulatory Agencies and the Swiss Agency for Therapeutic Products in the future.
Pages: 39, Annexes: 2
The aim of this master thesis is to investigate similarities and differences of Marketing Authorisation procedures for medicinal products in the European Union and in Switzerland, paying particular attention to the recent developments, and to provide an overview of current legislation for internationally operating companies wishing to obtain approval in Switzerland as well as for Swiss subsidiaries aiming to understand current European processes. To narrow the discussion to innovative medicinal products, the comparison is limited to Marketing Authorisation procedures for the product group of biotechnologically derived medicinal products, which have produced breakthroughs in the treatment of serious diseases including cancers, neurological disorders, diabetes, multiple sclerosis, enzyme deficiency diseases and arthritis.
The current regulatory framework is compared with respect to the provisions for standard Marketing Authorisation procedures for biotechnologically derived medicinal products and is also analysed for its possibilities to accelerate the assessment procedure and to make innovative, therapeutically needed medicinal products available to patients as soon as possible. Additionally, as an outlook, current legal pathways for approving similar biological products (biosimilars) are investigated.
In summary, standard Marketing Authorisation procedures for biotechnologically derived medicinal products are comparable in actual assessment times, not including clock-stops. A clear difference can however be observed in the possibility of meetings and oral hearings before or during the assessment procedure, the course of the assessment procedure and the time-point for provision of additional data after the Marketing Authorisation application. With respect to the possibility of accelerating the assessment procedure, the basic concepts will essentially be comparable in the European Union and in Switzerland after coming into force of the remaining provisions of the revised European legislation and the new package of ordinances in Switzerland. However, differences like access criteria for procedures, the course of procedures and the time frames needed for assessment, are still an obstacle for internationally operating companies aiming to obtain approval for innovative medicinal products within short time. A greater grade of harmonisation of Swiss provisions to European legislation is therefore welcomed, which could also facilitate stronger collaboration and exchange of assessment results between European Regulatory Agencies and the Swiss Agency for Therapeutic Products in the future.
Pages: 39, Annexes: 2