Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of Pharmacovigilance in Germany and Japan ***

Alice Burger (Abschlußjahr: 2017)

Summary
Language: English
The most important international organisation for harmonising pharmaceutical requirements is the "International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use" (ICH).  The European Union (EU) and Japan are both founding members of ICH.  However, although considerable work has been completed in other areas, there has been little harmonisation of pharmacovigilance requirements through ICH.  The EU and Japan have developed their own PV guidelines.  Germany, an EU Member State, has supplementary requirements in addition to EU requirements.  
Japan and Germany are the 3rd and 4th largest pharmaceutical markets in the world, and are highly attractive to potential marketing authorisation holders.  However, finding information and understanding the legal and operative framework of pharmacovigilance aspects can be difficult for non-German and non-Japanese speaking pharmaceutical professionals.  
This dissertation gives an overview of the international pharmacovigilance frameworks and the history and current approach to pharmacovigilance in Germany and Japan.  It explains and compares the main laws, the competent ministries/authorities, the relevant corporate structures and main activities in the pharmacovigilance lifecycle for each country.  The activities covered in this dissertation start with the submission of the product information and the risk management plan as part of the marketing authorisation application and then continue through the life-cycle of the medicinal product.  Reference to English versions of information is made whenever possible.
Pages: 78