Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Providing regulatory submissions in electronic format

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).”
  2. ICH S5 (R3) guideline on reproductive toxicology

    The European Medicines Agency have published: Scientific guideline: ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals, Step 5, adopted.
  3. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials

    The European Medicines Agency have published: Scientific guideline: ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, Step 5, adopted.
  4. Revision of Annex 1, on manufacturing of sterile medicinal products

    The European Commission has engaged a second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4.
  5. Evaluation of the immunotoxic potential of drugs and biologics

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.”