Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Overview of Regulatory Requirements for Marketing Authorisations of Pharmaceutical Products in Countries of Eurasian Economic Union

Dr. Valeria Ziemann (Abschlußjahr: 2016)

Summary
Language: English
On January 1, 2015, the Eurasian Economic Union (EAEU) was established as an international body with a legal personality. The intended purpose of the master thesis was to analyse regulatory requirements for marketing authorisation of medicinal products in the EAEU and its five member states: Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan. The concept of the creation of the common market for pharmaceutical products effective from the January 1, 2016 and challenges of the integration and harmonisation of the concerned national legislations regulating registration of medicinal products is presented and discussed. To achieve this goal, data obtained from official documents, legislative acts, websites, academic sources an own experience were collected, analysed and presented.
Significant similarities exist in the regulatory requirements for marketing authorizations in the EAEU countries; however, due to different industrial development and economic situation, national legislations regulating registration of pharmaceuticals in these countries are characterized also by significant differences. For this reason national marketing authorization procedures were not harmonized in the EAEU countries and there was no recognition of Registration Certificates for pharmaceutical products between countries before 2016.
Although the launch of the common pharmaceutical market which complies with the good pharmaceutical practices and based on uniform requirements was scheduled for January 1, 2016, the major process of regulatory harmonization between the EAEU countries is still far away from to be finalised. Development of a common pharmaceutical market and its regulatory system in the EAEU gives rise to many challenges among which the following factors are the most significant:

• discrepancy in regulatory requirements and possibilities of local pharmaceutical industry
• deficiency of qualified personnel
• general economic and global geopolitical situation

Nevertheless, expected benefits from the harmonisation of the regulatory frameworks in the EAEU member states will be among all stakeholders and will include reduction of the administrative barriers, cost effective use of resources, promotion of GxP, facilitation of cooperation between authorities, faster access to the quality safe and effective medicines.
Pages: 53