European Medicines Agency invites feedback on plans to revise existing guidelines on biosimilar medicines and influenza vaccines
The European Medicines Agency today published two concept papers for a three-month consultation period.
The papers seek stakeholders' views on the need to revise:
- the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues;
- the series of guidelines in place for influenza vaccines.
Feedback for both concept papers can be submitted until the end of December 2011. Once all feedback has been reviewed, the Agency will start the revision of the guidelines as appropriate.