EMA Updates Flu Vaccine Recommendations
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
On April 30, 2018, the European Medicines Agency (EMA) updated the European Union list of recommendations for influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season. The update contains a decision on suitable strains for live, attenuated vaccines. EMA also updated the list of reagents for vaccine standardization.
The ad-hoc Influenza Working Group initially made recommendations for the 2018/2019 flu vaccines on March 26, 2018. The list is developed on the basis of recommendations by the World Health Organization.
Applications to change the composition of centrally authorized flu vaccines are due by June 18, 2018.
Source: EMA
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
