| The value of the Pharmacovigilance System Master File (PSMF) and the commitment within industry to comply with the requirements are recognised and reflected in survey feedback received from Marketing Authorisation Holders. |
| The responses also showed that complex and varying international requirements are burdensome. |
| The authors would welcome dialogue between industry and national regulatory authorities with respect to globalisation of PSMF requirements, including their simplification and harmonisation. |
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