Nichi Iko says it has restarted production at its Namerikawa manufacturing plant after the Japanese firm was forced to suspend operations due to alleged GMP violations.

The French authorities believe that the “heterologous prime-boost” approach is justified in the case of people aged under 55 years who are due to receive their second dose of the AZ COVID-19 vaccine.

The newly published EU IDMP guide on implementing ISO data standards for the identification of medicinal products will keep regulatory affairs professionals busy with compliance work while also creating new data-driven opportunities for life sciences companies. Remco Munnik shares the inside track from his work with the EU focus group that created the guide.