New European pharmacovigilance legislation – what are pharma saying about it?

In Regulation and Compliance by aliceLeave a Comment

The new European pharmacovigilance legislation for human use – how is the industry responding to the changes and what are they expecting the impact will be on safety strategy and practical implications. We've been listening to the industry on this and its been great hearing what pharma has to shout about including their expectations, the good, the bad and the ugly. The backbone to the new legislation is its role in strengthen and rationalising the current system for monitoring the safety of medicines in Europe with a number of significant legislation developments affecting pharma and the way drug safety is monitored and reported upon. We asked in a recent survey what the industry saw as the most significant aspect of the new legislation in the way it impacts pharma. The big concern highlighted time and time again were:

  • The new EVMPD
  • New rules for ICSR reporting
  • The new PSUR format
  • The content and format of RMPs under the new system
  • How the MAH responsibilities and requirements will change
  • The impact of centralised and e-reporting
  • PASS and PAES studies
  • RMP effectiveness assessments
  • PRAC remit
  • Patient communication
  • PSMF

Do you agree with these or do you have an alternative suggestions of what the most significant changes will be over the next year?

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