Pharmacovigilance (PV) Legislation in Ukraine and the European Union (EU):
Pharmacovigilance in the EU:
Regulatory Body: The European Medicines Agency (EMA) coordinates PV activities, which are overseen by national competent authorities (NCAs) in each member state. The Good Pharmacovigilance Practices (GVP) guidelines provide a comprehensive framework for all EU member states.
Legal Framework: PV's legal basis is established through Regulation (EC) No. 726/2004 and Directive 2001/83/EC, updated by Regulation (EU) No. 1235/2010 and Directive 2010/84/EU. These laws mandate a harmonized approach across member states, ensuring that PV systems consistently monitor and assess the safety of medicinal products.
Key Elements:
Risk Management Plans (RMPs): These are required for all new drugs, ensuring that risks are monitored and mitigated throughout the product lifecycle.
EudraVigilance: The centralised ADR reporting system that collects and analyses adverse drug reactions from across the EU.
Qualified Person for Pharmacovigilance (QPPV): Each marketing authorisation holder (MAH) must appoint a QPPV to oversee compliance with GVP.
Periodic Safety Update Reports (PSURs): Regular reports evaluating the benefit-risk balance of medicinal products must be submitted.
Signal Management: Active surveillance of adverse reactions and identification of safety signals.
Transparency: Public access to safety data through the EudraVigilance database allows stakeholders and the public to view ADR reports and the safety profile of medicines.
Pharmacovigilance in Ukraine:
Regulatory Body: The State Expert Center of the Ministry of Health of Ukraine (SEC) is responsible for PV activities. It operates within the Ukrainian Ministry of Health framework and follows national legislation and international standards, including ICH guidelines and GVP.
Legal Framework: Ukraine's PV system is based on the Law of Ukraine on Medicines and several key regulations that govern the safety monitoring of medicinal products. In recent years, Ukraine has worked to align its regulatory system with EU standards, particularly since the 2014 Association Agreement with the EU.
Key Elements:
National PV System: The SEC manages ADR reporting through the National Pharmacovigilance System, which collects reports from healthcare professionals and patients.
Risk Management: Ukraine has adopted Risk Management Plans (RMPs) for new medicinal products, similar to the EU’s requirements.
PSURs: Periodic reports on drug safety are required to maintain the drug's marketing authorisation.
Signal Detection: Ukraine uses a combination of manual review and electronic systems to detect and evaluate safety signals from ADR reports.
Alignment with EU GVP: Ukraine is progressively aligning with EU GVP standards, especially regarding reporting requirements, risk management, and ADR monitoring. This alignment is part of Ukraine's goal of closer integration with European regulatory frameworks.
Transparency: The National Pharmacovigilance System allows public access to safety data, but the system is less centralised compared to the EU’s EudraVigilance. Public reporting is primarily managed through national resources, with growing integration into broader international PV networks.
Comparative Analysis:
Regulatory Alignment: The EU has a fully harmonised PV system through GVP guidelines and EudraVigilance, while Ukraine is still in the process of aligning its PV legislation with EU standards, particularly through its national system managed by the SEC.
Risk Management: Both the EU and Ukraine require Risk Management Plans (RMPs) for new medicinal products, but Ukraine is still developing its capacity for extensive post-market surveillance and signal detection.
ADR Reporting Systems: The EU’s EudraVigilance system is centralized and widely accessible, while Ukraine’s ADR system is more fragmented but undergoing improvements as part of the integration with European standards.
Transparency and Public Access: The EU provides broader access to safety data through EudraVigilance, while Ukraine’s public reporting and transparency mechanisms are still developing but are set to improve with increased digitalization and alignment with EU practices.
Conclusion:
Ukraine is making substantial progress in aligning its pharmacovigilance system with EU standards, particularly since the EU-Ukraine Association Agreement. However, challenges remain in achieving the same level of centralization and harmonization as seen in the EU’s EudraVigilance system. With continued regulatory reforms and integration efforts, Ukraine is moving towards a more robust and transparent PV framework in line with EU regulations.
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