March 10, 2014
The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now. EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.
Most of MAH and Sponsors have earlier submitted EVMPD data; however the latest mandate requires all the stake holders to resubmit the XEVMPD submission effective from June 16 2014 to December 31 2014. This mandate will see a deluge of re-submissions on the EVWeb, a tool provided by the EudraVigilance.
Let’s have a brief insight into the EVMPD user manual!
What is EVMPD?
EVMPD stands for EudraVigilance Medicinal Product Dictionary and EudraVigilance stands for European Union Drug Regulating Authorities Pharmacovigilance. This pharmacovigilance system is basically run by the European Medicine Agency.
What is XEVMPD?
XEVMPD stands for Extended EudraVigilance Medicinal Product Dictionary.
EudraVigilance database was established in December 2001 by the EMA. This data processing management system usually involves reporting about the dubious ADRs (adverse drug reactions) that occur during the development. Furthermore, EVMPD deals with post marketing authorisation approval of medicinal products for human use in the European Economic Area including Iceland, Norway and Lichtenstein.
Role of EudraVigilance
The initial role of EudraVigilance involved electronic exchange of details of adverse reaction reports between the national competent authorities, EMA, marketing authorisation holders and clinical trial sponsors. XEVMPD works towards early detection of safety signals on medicinal products for human use. This early detection is then followed by facilitating prolonged monitoring potential safety issues if any. In this way, the probable risks to patients are detected, assessed and reduced.
In 2012 XEVMPD becomes mandatory
On 2nd July, 2012 XEVMPD became mandatory for all MAHs and submission of product details to the EVMPD was not voluntary anymore. The stigma was for marketing authorisation holders, who were forced to submit data of all their sanctioned substances once again either by manually typing the data on the EVWEB web portal page or through electronically from other systems.
Guidelines for EVMPD
- 5 new fields – Five new units are mandatory for all sanctioned medicinal products
- Correction of errors – Any errors and omissions in the already-submitted data are to be corrected for human use
- Updating data within 30 days – Once legitimate, the data should be updated within 1 month by using the ‘Update’ process instead of previously used complex ‘Variation’ process
- Create a Product Report with the Operation Type “Insert” – In order to add a new Authorised or Development Medicinal Product in the XEVMPD one needs to add a Product Report in the XEVPRM with the operation type “Insert”.
XEVMPD: The Challenges
MAH and Sponsors, who are submitting new and existing medicinal products while managing the process internally, are required to run through the entire latest XEVMPD mandate, are required to use the EVWeb tool for their submissions and are also required have an in-depth understanding of all the norms of EMVPD, XEVMPD and its expected transition to ISO IDMP.
Anomalies with EVWEB
- Data Repository: Acknowledgement files cannot be retrieved after few days of submission and furthermore EVWEB does not feature a repository for storing these Ack files.
- Product Data: EVWEB is specifically designed to handle less number of products and companies having extensive medicinal products will be unable to make use of the tool.
- Audit Trials and Reports: EVWEB does not possess the reports and audits status tracking feature, making it difficult to capture the changes to metadata and user who has changed it.
In case if there is an error in product information (e.g.: ATC Codes) the record will be rejected. In such circumstances user must re-enter the data for submitting the same product information. It’s a time consuming process.
XEVMPD Submissions Roadmap – The Efficient, Effective and Proven Approach
Having envisioned these hurdles, Freyr Solutions, a Global Regulatory Service and Solutions company, has developed an integrated solution and services offering that efficiently streamlines the entire process of XEVMPD submissions.
Freyr – Trusted Partner for XEVMPD Services & Solutions
Freyr XEVMPD solution is a complete automated submission system that validates the product information and creates EMA compliant EVMPD XML files. The solution is easy-to-use, hosted, on-demand web-based solution for information management with state-of-the-art navigation and user interface components.
Advanced Features that Score over EVWEB
- XEVMPD business rule validation
- Possibility of XML editing directly on Freyr XEVMPD system
- Provision of multi-level data security
- Availability of import feature in controlled vocabularies section
- Clone feature saves time in creating duplicate records if any product is available in different strengths
- Effective management of Acknowledgement files (easily retrievable)
Freyr’s XEVMPD solution & services offer 100% on-time submissions while enabling significant savings of over 40% in compliance costs and helping companies reduce their submission turnaround time by up to 80%.
EU’s new drug identification standards
Recently the European Medicines Agency (EMA) announced that it would be creating a task force so as to supervise the implementation of latest standards set up for identifying quality of drugs. The goal of this task force would mainly involve a roadmap for EU-wide implementation of identification of medicinal products (IDMP) standards as developed by the International Organization for Standardization (ISO).
The European Medicines Agency recently issued an analytical document – Data submission of authorised medicines in the European Union. In this document, EMA has talked about replacing its current eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) with IDMP standards.
While EMA has appealed for volunteers to participate in the EU ISO IDMP Task Force, at Freyr our task force is already constructing a roadmap that is focused at gap analysis comparing XEVMPD and ISO IDMP.
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