Masterstudiengang "Drug Regulatory Affairs"


New developments in European registration procedures and requirements, in particular consideration of biological/biotechnological-derived medicinal products

Dr. Frank Jeblonski (Abschlußjahr: 2007)

Language: English

The European pharmaceutical law has been changed and developed furtheron. Transparency rules has been established in the European registration procedure to create an environment of trust and collaboration, thus increasing the predictability for a new medicinal product in the scientific evaluation. The need for more and more effective medicines for children has also been strenghtened and fostered by the European Commission. The harmonisation of intellectual property rights (IPR) as well as a good benchmarking system to strenghten the competition among the national competent authorities is still in progress.

The bio(techno)logical industry in Europe has initiated the development of new kinds of medicinal products, smoothed by new pharmaceutical legislation. Thereby, the biotechnology has revolutionised medicine. It will contribute further to better ways to prevention and treatment of diseases and thereby further improve quality of life and extend life expectancy.

Medicinal products for advanced therapies are suggested to have the largest innovative potential for adequate treatment of untreatable diseases until now. The different national legislations have been nearly harmonised, especially as concerns stem cells, presumably the field with the most innovative potential. The positive and promising character of MP for advanced therapies has been strained by an incident last year, resulting in new guidelines on clinical testing (first-inman).

Biosimilars have been established on the market as a new trend in the Biopharmaceutical medicines.
This field of pharmaceutical industry is strongly connected with small and medium sized enterprises (SMEs) which describes a high share on the deveopment of biological medicinal products. The high relevance of SMEs for the amount of innovation has been realised and sponsored very intensively.
Today, Europe ranks at the second position in the pharmaceutical market

Pages: 73
Annexes: 10 pages