Understanding the EURD list: European Union Reference Date
The European Medicines Agency (EMA) maintains various critical tools to ensure the safety and efficacy of medicinal products in the European Union. Among these tools is the EURD list, a vital resource for pharmaceutical companies and regulatory bodies. This article will provide a detailed overview of what the EURD list is, its importance in drug safety monitoring, and how companies can utilize it effectively to comply with European pharmacovigilance requirements.
What is the EURD List?
The EURD (European Union Reference Date) list is a comprehensive schedule maintained by the European Medicines Agency. It outlines the European Union reference dates and the corresponding frequency of submission of periodic safety update reports (PSURs) for medicinal products. The list is essential for ensuring that PSURs are submitted in a harmonized manner across the EU, which is critical for the ongoing monitoring of drug safety.
Key Aspects of the EURD List:
European Union Reference Date (EURD): This is the date from which the clock starts for the calculation of the PSUR submission frequency for a particular medicinal product. The EURD is typically based on the first marketing authorization date of the product within the EU or the International Birth Date (IBD).
PSUR Submission Frequency: The EURD list specifies how often pharmaceutical companies must submit PSURs for their products. This frequency is determined based on factors such as the risk profile of the drug, its therapeutic class, and the time since its initial approval.
List Updates: The EURD list is regularly updated by the EMA to reflect new safety information, changes in regulatory requirements, or the availability of new medicinal products. Companies must stay informed about these updates to ensure compliance with their PSUR obligations.
Importance of the EURD List
Regulatory Compliance: Compliance with the EURD list is mandatory for all pharmaceutical companies operating within the European Union. Adhering to the specified PSUR submission schedules ensures that companies meet their regulatory obligations and contribute to the continuous assessment of drug safety.
Harmonized Reporting: The EURD list facilitates harmonized reporting across the EU, ensuring that all member states receive PSURs simultaneously. This harmonization is crucial for the effective monitoring of medicinal products on a European scale.
Risk Management: By adhering to the EURD list, companies can help identify, assess, and mitigate potential risks associated with their products. Regular submission of PSURs allows for the timely detection of safety signals, enabling prompt regulatory action if necessary.
The EURD list is a critical tool in the European pharmacovigilance landscape. By understanding its importance and adhering to the specified PSUR submission schedules, pharmaceutical companies can ensure compliance with EU regulations and contribute to the ongoing safety monitoring of medicinal products. Whether you are a regulatory affairs professional, a pharmacovigilance specialist, or a pharmaceutical company executive, staying informed about the EURD list is essential for navigating the complexities of drug safety reporting in Europe.
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