Recent updates: EU pharmacovigilance legislation

In Regulation and Compliance by aliceLeave a Comment

I caught up on how the EU pharmacovigilance legislation has been progressing today on the EMAs website. I wanted to highlight a few of the most recent developments that will be affecting the pharma industry. There is lots of information being released to help guide, advise and influence the integration of the new legislation into pharma's pharmacovigilance strategy and operations. Some of the most recent and significant updates include:
FEBRUARY: The EMA released information on 7 new good pharmacovgilance practice (GVP) modules for public consultation. These were:
  1. Pharmacovigilance systems and their quality systems
  2. Pharmacovigilance systems master files
  3. Risk management systems
  4. Management and reporting of adverse reactions to medicinal products
  5. Periodic safety update reports
  6. Post-authorisation safety studies
  7. Signal management

FEBRUARY: The EU Commission provided information on the transitional crossover period between some of the new and old submission deadlines under the new pharmacovigilance legislation in  Europe. Information was released for renewal applications, marketing authorisation applications, pharmacovigilance system master files, risk management plans, referrals and periodic safety update reports.

MARCH: The EMA has published mandatory Article 57(2) requirements for marketing authorisation holders and put a number of measures in place to streamline the process and help MAH meet the 2nd July deadline. These include reducing the admin workload, putting in place a support network and helpdesk and an online data entry tool EVWEB for small/mid size pharma.

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