Changes in the registration dossier for influenza vaccines

At a meeting of the Eurasian Economic Commission (EEС) on June 14, unified approaches to the procedure for amending the registration vaccines’ documents for the prevention of influenza were adopted. Uniform requirements to the structure, content, format and scope of the registration dossier, procedures for amending the dossier, its expertise, and the timing of applications for registration were also established.

The flu is caused by the smallest biological fractions – viruses. It belongs to the group of RNA-containing viruses, that is, viruses that store genetic information in the RNA molecule. In total, three types of the virus are known – A, B and C, within which virologists isolate individual strains and serotypes, depending on which proteins contain the influenza virus.

The composition of vaccines varies annually, which is due to the variability of this virus. A characteristic feature of the influenza virus is its ability to permanently mutate. And this means that every year new strains appear, and if a person has had flu and acquired resistance to infection with one strain, it does not mean that he or she will not be able to catch the disease caused by another strain of the virus next year.

The current requirements for the production of vaccines and vaccination of the population in order to prevent epidemics and pandemics of influenza do not allow the standard procedure for 210 days to be applied to the registration of these drugs, as well as the introduction of changes therein. That is why a reduced order of evaluation of this vaccines group was introduced when making adjustments to the registration dossier related to the change in the strain of influenza. Now the term of the procedure for making changes to the registration dossier should not exceed 40 calendar days.

Source: Pharmvestnik.