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EU's new pharmacovigilance legislation: considerations for biosimilars
1Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country, P. Universidad, 7, 01006, Vitoria-Gasteiz, Spain, b.calvo@ehu.es.
Drug Safety
|November 6, 2013
Summary
New European pharmacovigilance legislation streamlines risk management for all medicines, including biosimilars. This ensures robust safety monitoring and benefit-risk assessment for biological medicines and other drugs.
Area of Science:
- Pharmacovigilance
- Regulatory Science
- Pharmaceutical Policy
Background:
- Biosimilars are highly similar to authorized biologics.
- Marketing authorization requires a risk-management plan (RMP)/pharmacovigilance plan.
- Plans must address pre- and post-authorization risks.
Purpose of the Study:
- Analyze new European Pharmacovigilance System requirements.
- Focus on medicines needing additional monitoring, like biosimilars.
- Detail obligations for marketing authorization holders.
Main Methods:
- Review of new European pharmacovigilance legislation.
- Analysis of requirements for risk management and data collection.
- Examination of obligations for marketing authorization holders.
Main Results:
- New legislation ensures risk management via adverse drug reaction recording and stakeholder data collection.
- Reduced administrative burden for companies and agencies.
- Clear establishment of responsibilities and avoidance of duplicated efforts.
Conclusions:
- Biosimilars are priorities for pharmacovigilance under the new regulations.
- Continuous benefit-risk assessment is a key obligation for marketing authorization holders.
- The updated system enhances safety monitoring for biological medicines.
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