Important modifications in pharmacovigilance of the EAEU in 2017
2017 was an important date in the history of pharmacovigilance in Russia and the countries of the Eurasian Economic Union (EAEU). The legal framework for pharmacovigilance activities was completely updated and unified rules for pharmacovigilance were introduced for all EAEU member countries in accordance with the requirements of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union (Decision №87 of 03.11.2016).
The agreements of the EAEU countries on the general principles of drug circulation indicate that national pharmacovigilance systems are brought into compliance with the Good Pharmacovigilance Practices, and there is no transition period.
At the moment the legislations of the EAEU member countries are harmonized with the requirements of the Good Practice. For example, in Russia in February 2017 Order No. 1071 “On Approval of the Procedure for Pharmacovigilance” was approved, and in Armenia Order No. N23-N of May 17, 2017. “On approval of the procedure for registration, collection, reporting and reporting, monitoring and analysis of data on suspected adverse reactions, lack of therapeutic effectiveness, misuse and suspected falsification of medicines, as well as the registration log form and the report card on suspected adverse reactions, lack of therapeutic effectiveness, misuse and suspected falsification of medicines”.
In the near future it is also planned to introduce rules governing the inspection of pharmacovigilance systems of holders of drug registration certificates.
Already now such requirements are mandatory as:
- Designation of a Pharmacovigilance Authorized Person in each Company;
- Development and maintenance of the Pharmacovigilance System Master File;
- Development and implementation of standard operating procedures describing all drug safety management processes;
- Having a validated database to store drug safety information;
- Collection, registration and timely reporting of information on cases of adverse reactions during the use of medicines;
- Development and timely submission of periodic safety reports on both registered and investigational drugs;
- Conducting regular audits of the pharmacovigilance system;
- Arranging for proper storage and archiving of pharmacovigilance documentation.
Good pharmacovigilance practices and local legislative acts of EAEU member states regulate strict requirements for the Authorized person on pharmacovigilance, his education, and qualification, as well as a significant number of requirements to the organization of storage of data related to pharmacovigilance (presence of “audit trail”, protection of access to confidential patient data, etc.), strict terms of safety information, ongoing risk-benefitq assessment of all medicines and periodic audits of their system Because of this, an increasing number of pharmaceutical companies, are turning to firms that provide professional pharmacovigilance services. This allows both budget savings and highly qualified services without the time and effort required to recruit staff, train them constantly, and constantly monitor the new regulatory requirements adopted by different countries.