Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of the regulation for Good Pharmacovigilance Practice in the European Union and in the Eurasian Economic Union ***

Dr. Natalia Osmanova (Abschlußjahr: 2018)

Summary
Language: English
The Rules on Good Pharmacovigilance Practices (GVP) of the EAEU approved by the Decision № 87 of the Eurasian Economic Commission from 03.11.2016 utilizes European pharmacovigilance principles.
Even though the GVP Rules will only be applicable to the products registered under the "common EAEU-procedure" – which offers a slight time advantage, the Marketing Authorisation Holders and Competent Authorities of the EAEU Member States got the great scope of work in front of them.
The immediate tasks of the Marketing Authorisation Holder are: preparation of the Risk Management Plans for each product; planning and conducting audits of the pharmacovigilance system; designating a Qualified Person Responsible for Pharmacovigilance (QPPV) in the EAEU territory and his/her training on the pharmacovigilance system; creation of Periodic Safety Reports.
The immediate tasks of the pharmacovigilance departments of the Competent Authorities are: development and harmonisation of the reference dates list for submission schedules of Periodic Safety Reports; conduction of the pharmacovigilance systems inspection, and development of the respective documents; education of specialists.
The Decision №87 on Good Pharmacovigilance Practices is the first attempt to create an effective pharmacovigilance tool for the Common Market for Medicines in the EAEU, and so the need for further developments and enchantments can be already estimated.
The process of the implementation and harmonisation of the EAEU-GVP is still awhile away from now and only joint efforts of all involved parties (Marketing Authorisation Holders, Competent Authorities of the EAEU Member States, health-professionals and patients) will contribute to the improvement of pharmacovigilance in the EAEU, thus assuring the high quality of the public health care system in each Member State.
Pages: 55, Annexes 4: pages: 88