Comparison of Pharmacovigilance Regulations in Europe and Japan eBooklet*

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It has been getting more important for MAHs to comprehend PV regulations and regulatory expectations in Europe and Japan since PV activities should be a global system in itself. Considering the importance of stakeholders in the European Union and Japan in producing hiqh quality medicinal products around the world and their determining role in directing drug safety regulations, it is important to compare these regulations and expectations and to clarify the different aspects of PV activities and their characteristics. Therefore, the Research Quality Association (RQA) and the Japanese Society of Quality Assurance (JSQA) initiated a joint effort in which the regulations from both continents are compared in order to bring the similarities and differences in each of the important topics for PV. This booklet reflects the similarities and differences in the form of short versions for each of the subjects, furthermore a summary table is also incorporated at the end of it on order to have a quick view of all these comparisons and the related document which has served as reference. 

Contents

1. Additional monitoring

2. Aggregate reporting

3. Evaluation of Safety Data

4. ICSR Reporting

5. Inspections

6. Literature Search

7. Pharmacovigilance System Master File

8. Post Marketing Studies

9. QPPV

10. Quality Management System

11. Reference Safety Information

12. Risk Management Plan (RMP)

13. Safety Communication

14. Signal detection

Authors

RQA 
Project Leader - Ana-Maria Aguirre-Arteta, F. Hoffmann-La Roche Ltd
plus PV Committee members

JSQA 
Project Leader - Genshu Nakamura, Biogen Japan Ltd
plus JSQA members