Top 5 Articles

Latest regulatory information from the EIPG Website
  1. Quality of water for pharmaceutical use

    The European Medicines Agency have published: Scientific guideline: Draft guideline on the quality of water for pharmaceutical use, draft: consultation open.
  2. Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease

    The European Medicines Agency have published: Scientific guideline: Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1), draft: consultation open.
  3. Metastasis-free survival endpoint in clinical trials for nonmetastatic, castration-resistant prostate cancer

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials.”
  4. Use of patient disease registries for regulatory purposes

    The European Medicines Agency have published: Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations, draft: consultation open.
  5. Quality aspects included in the product information for vaccines for human use

    The European Medicines Agency have published: Scientific guideline: Guideline on quality aspects included in the product information for vaccines for human use – Revision 1, adopted.