Scientific Guidelines

Scientific guidelines (human and veterinary)

  1. ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

    ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

  2. Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

    Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes

  3. Draft guideline on the quality aspects of mRNA vaccines

    Draft guideline on the quality aspects of mRNA vaccines