Effective: August 6, 2024

Guidance is being assessed for impact by PS and Reg Affairs and further communication will be disseminated.

The changes made in revision 3 of the GVP Module XVI included:

  • Clarifications in XVI.A 
    • to specify the role of risk minimization for risk management planning and its impact on the risk-benefit balance of medicinal products.
  • Addition of XVI.B.2.
    • Provided more guidance on the criteria for applying/requesting additional risk minimization measures.
  • Introduction of a new classification for educational materials in XVI.B.3.1.
  • Modifications in XVI.B.3.4.
    • Concerning the concept of controlled access systems and the inclusion of examples illustrating the requirements.
  • Addition of XVI.B.4.
    • to clarify the role of risk communication, dissemination, and implementation as a significant part of any additional risk minimization activity.
  • Enhanced guidance in XVI.B.5.
    • On criteria and methods for risk minimization evaluation, emphasizing an iterative planned and prospective approach with integrated measurement of different elements and regulatory follow-up.
  • Detailed guidance in XVI.B.5.4.
    • On risk minimization evaluation parameters, suitable study designs, and data collection methods.
  • Inclusion of XVI.B.7.
    • to provide recommendations on additional risk minimization measures within the product's lifecycle.
  • Modifications in XVI.C.3.
    • to provide more details on the role of healthcare professionals and patients, along with strategies for their early engagement in risk minimization development, dissemination, and evaluation.
  • Deletion of Appendix I on survey methodologies and integration of this guidance in Addendum II of the Module.

 

Guideline on Good Pharmacovigilance Practices (GVP) Annex I - Definitions (Rev 5)

Effective: August 6, 2024

Summary of Updates:

  1. Adverse Event Definition:
    • Deleted the previous definition under Dir 2001/20/EC.
    • Updated to Reg (EU) No 536/2014 as defined in GVP A I Rev 4.
    • For pharmacovigilance outside clinical trials, the definition follows ICH-E2D.
  2. Adverse Reaction Definition:
    • Deleted Footnote 1 in GVP A I Rev 4 referencing Dir 2001/20/EC.
    • Updated to Reg (EU) No 536/2014, referring to DIR 2001/83/EC for clinical trials.
  3. Clinical Study Definition:
    • Deleted note on the applicability under Reg (EU) No 536/2014.
    • The definition is already included in GVP A I Rev 4.
  4. Clinical Trial Definition:
    • Deleted the previous definition under Dir 2001/20/EC.
    • Updated to Reg (EU) No 536/2014 as per GVP A I Rev 4.
  5. Disease Registry:
    • Added definition per CHMP Guideline on Registry-based Studies.
  6. Healthcare Professional Definition:
    • Updated according to GVP Module XVI Rev 3.
  7. New Definitions:
    1. Immunisation Stress-Related Response (ISRR): Added to supplement other adverse event definitions.
    2. Patient: Added per GVP Module XVI Rev 3.
    3. Primary Data Collection: Added per CHMP Guideline on Registry-based Studies.
    4. Registry-Based Study: Added per CHMP Guideline.
    5. Registry Database: Added per CHMP Guideline.
    6. Secondary Use of Data: Added per CHMP Guideline.
    7. Target Population (Risk Minimisation Measure): Added per GVP Module XVI Rev 3.
  8. Deleted Definitions and Notes:
    1. Individual Case Safety Report: Deleted Footnote 11 in GVP A I Rev 4.
    2. Investigational Medicinal Product: Deleted previous definition under Dir 2001/20/EC.
    3. Low-Intervention Clinical Trial: Deleted note on the definition applicability.
    4. Non-Interventional Trial: Deleted previous definition under Dir 2001/20/EC.
    5. Normal Clinical Practice: Deleted note on the definition applicability.
    6. Registry: Deleted previous definition.
    7. Unexpected Adverse Reaction: Deleted text in Footnote 17 in GVP A I Rev 4.
  9. Updated Definitions:
    1. Medical Device: Updated per Reg (EU) 2017/745.
    2. Medication Error: Added explanatory notes per EMA-PRAC Good Practice Guide.
    3. Patient Registry: Added per CHMP Guideline.
    4. Risk Minimisation Measure: Added explanatory notes per GVP Module XVI Rev 3.
  10. Editorial Improvements:
    1. Improved the alphabetical order and clarity of several definition entries.
  11. References:
    1. Added a reference to Annex I of the Questions & Answers Document - Regulation (EU) 536/2014, Volume 10 of the Rules Governing Medicinal Products in the EU.