The EudraVigilance Medicinal Product Dictionary (EVMPD), also known as the Article 57 Database, is a centralized database maintained by the European Medicines Agency (EMA). It serves as a key tool for the collection, management, and analysis of medicinal product information in the European Union (EU). The EVMPD is part of the broader EudraVigilance system, which is the EU’s centralized system for monitoring the safety of medicinal products used within the region.
1. Purpose of the EudraVigilance Medicinal Product Dictionary
The primary role of the EVMPD is to support pharmacovigilance activities and ensure regulatory compliance by creating a structured and standardized repository of medicinal products authorized for use in the EU. It helps the EMA and national regulatory authorities to:
Collect and manage data on medicinal products in a standardized format.
Monitor and track safety signals and adverse events associated with specific medicinal products.
Streamline regulatory processes, such as product authorizations and variations.
The EVMPD facilitates compliance with pharmacovigilance legislation (as required under Article 57(2) of Regulation (EC) No 726/2004), which mandates that pharmaceutical companies must submit detailed product information for all authorized medicinal products to the database.
2. Scope and Contents of EVMPD
The EVMPD covers information about:
Centrally authorized products: Drugs approved by the EMA through the centralized procedure.
Nationally authorized products: Medicines approved by national regulatory agencies in individual EU member states.
Active substances: The pharmacologically active components of medicinal products.
Pharmaceutical forms: Different dosage forms such as tablets, injections, and solutions.
Manufacturing information: Details about the manufacturer of the medicinal product.
Marketing authorization holders (MAHs): Companies responsible for the medicinal product.
Pharmaceutical companies must submit detailed product information for all products authorized for sale in the EU, as well as any subsequent updates or variations.
3. Data Fields in EVMPD
The EVMPD requires the submission of several mandatory data fields for each medicinal product, including:
Product name: The proprietary or brand name of the drug.
Active substance: The name and details of the active ingredient(s).
Pharmaceutical form: The physical form of the drug (e.g., tablet, capsule, injection).
Route of administration: The way the drug is administered (e.g., oral, intravenous).
Strength: The dosage or concentration of the active substance.
Marketing authorization number: The official authorization number for the medicinal product.
Marketing authorization holder (MAH): The company that holds the marketing authorization for the product.
Country-specific data: Information about the markets where the drug is authorized, along with variations in product formulations.
4. Pharmaceutical Companies’ Responsibilities
Pharmaceutical companies must ensure that all medicinal products they market within the EU are registered and maintained in the EVMPD. This includes:
Initial submission of product information: When a medicinal product is first authorized.
Maintenance of the data: Updating the product information if there are any changes to the authorization, such as a new dosage form, change in the manufacturer, or withdrawal of the product.
Annual updates: Companies must submit annual updates to confirm that the product is still on the market.
Failure to comply with these reporting requirements can result in penalties, such as delays in product approvals or suspension of marketing authorizations.
5. Integration with EudraVigilance and Pharmacovigilance
The EudraVigilance system, of which the EVMPD is a component, is the central EU database for managing adverse drug reaction (ADR) reports and other pharmacovigilance data. The EVMPD plays a critical role in ensuring that ADRs can be linked to the correct medicinal product by providing standardized and up-to-date product information.
When a suspected adverse drug reaction (ADR) is reported, the product information from the EVMPD helps identify the exact product and formulation involved. This is essential for accurate signal detection and risk assessment.
6. Benefits of the EVMPD
The EVMPD provides several key benefits for regulators, pharmaceutical companies, and healthcare providers:
Improved Drug Safety Monitoring: By maintaining an accurate and comprehensive database of all medicinal products in the EU, the EVMPD helps to ensure that ADRs can be correctly attributed to the right product, enhancing the accuracy of safety monitoring.
Standardization: The database promotes consistent and standardized reporting of product information, facilitating regulatory submissions, product authorizations, and safety reports across EU member states.
Data Sharing: The EVMPD allows for efficient sharing of product information across the EU, improving collaboration between regulatory authorities and ensuring faster responses to safety signals and public health concerns.
Regulatory Compliance: For pharmaceutical companies, maintaining up-to-date information in the EVMPD ensures compliance with EU pharmacovigilance legislation and avoids potential regulatory penalties.
7. Examples of Data Entries in EVMPD
Example 1: Amoxicillin
Product Name: Amoxicillin Sandoz
Active Substance: Amoxicillin
Pharmaceutical Form: Tablet, oral suspension
Strength: 500 mg, 1 g
Marketing Authorization Holder (MAH): Sandoz GmbH
Route of Administration: Oral
Marketing Authorization Number: EU/1/12/ABC1234
Example 2: Insulin glargine
Product Name: Lantus
Active Substance: Insulin glargine
Pharmaceutical Form: Injection
Strength: 100 IU/mL
Marketing Authorization Holder (MAH): Sanofi-Aventis
Route of Administration: Subcutaneous injection
Marketing Authorization Number: EU/2/08/XYZ5678
8. Relation to Other Drug Dictionaries
The EVMPD is a European database, distinct from other international drug dictionaries such as the WHO Drug Dictionary or MedDRA:
WHO Drug Dictionary: A global drug dictionary used primarily in pharmacovigilance to standardize drug names and formulations.
MedDRA: Focuses on medical terminology related to adverse events, not specifically on drug products.
FDA’s NDC Directory: A U.S.-specific drug dictionary containing information about drug products authorized for use in the United States.
9. Challenges and Future Developments
Although the EVMPD is a critical component of pharmacovigilance in the EU, challenges remain, such as:
Data Submission Complexity: The process of submitting and updating data can be time-consuming for pharmaceutical companies, particularly for those with a large product portfolio.
Data Quality: Ensuring that the data submitted is accurate and complete can be challenging, and errors in the database can impact pharmacovigilance activities.
Harmonization with Global Standards: Efforts are ongoing to further align the EVMPD with global databases and standards, ensuring better international cooperation in drug safety monitoring.
In the future, enhancements to the EVMPD, such as more automated data submission processes and better integration with global pharmacovigilance systems, are expected to further improve its utility for both regulators and industry stakeholders.
Conclusion
The EudraVigilance Medicinal Product Dictionary (EVMPD) is an essential tool for ensuring the safe and effective use of medicines within the EU. By providing a comprehensive and standardized database of medicinal products, it supports pharmacovigilance activities, ensures regulatory compliance, and facilitates the detection of safety signals. For pharmaceutical companies, maintaining accurate and up-to-date information in the EVMPD is critical for complying with EU legislation and ensuring that their products are correctly monitored for safety.