December 2001 the European Medicines Agency (EMA) launched EudraVigilance
In December 2001 the EMA launched EudraVigiliance (Regulation (EC) No. 726/2004). This regulation is also known as Article 57 as it is the 57th article in legislation. EudraVigilance is a data management system designed to assist with data processing and evaluation activities during development and post marketing of medicinal products authorised in the European Economic Association (EEA). EudraVigilance has two main reporting functionalities.
Firstly it is used as a gateway to submit information on suspected adverse drug reactions. EudraVigilance allows users to pass details of adverse reaction reports electronically between the European Medicines Agency (EMA), Competent Authorities (CAs) and Marketing Authorisation Holder’s (MAHs) helping to improve the detection and assessment of signals.
The second key functionality of Eudravigilance is for the submission of information on medicinal products which creates a live product dictionary. In this article, I will focus on the Extended EurdraVigilance Medicinal Product Dictionary.
2005 EudraVigilance Medicinal Product Dictionary (EVMPD) was created
In 2005 the EudraVigilance Medicinal Product Dictionary was created by the EMA. EVMPD was created to establish a list of all human products authorised within the EEA. This information helps to assist with pharmacovigilance and regulatory activities with the aim of improving the processing and management of product information. An example of the use of this data is in the calculation of the mandatory PV fees. Since 2005 MAHs have been able to submit details of their products through EVMPD to the EMA, although this process was not initially mandatory.
December 2010 Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) was created and became a mandatory requirement
In December 2010 the original legislation (Regulation (EU) No. 1235/2010) was amended in the EU. Becoming article 57(2). The changes in legalisation led to EVMPD (EudraVigilance Medicinal Product Dictionary) being re-branded as XEVMPD (Extended EudraVigilance Medicinal Product Dictionary). This rebrand to XEVMPD was to reflect the further information which was now required for MAHs to submit and to also highlight the significant changes to legislation. Until this time EVMPD had been an optional requirement, but with the updated pharmacovigilance legislation, XEVMPD became a mandatory requirement for MAHs. Changes to the legislation included the submission of product information for each marketing authorisation becoming a mandatory process for MAHs by the 2nd of July 2012. Further changes included MAHs having a responsibility to keep their product information up to date as well as submitting further information on their products than what was outlined in the original guidance. For example, information being provided on excipients as well as providing a copy of the SmPC with each upload. The EMA outlined in the legislation that the information provided through XEVMPD would allow a list of all authorised medicinal products in the EU to be created.
Legal Notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004
Following on from the July 2012 deadline, the EMA ran quality checks on product information which had been uploaded to XEVMPD. The validation of information showed many errors within the information provided, such as duplication of excipients, incorrect terms and incorrect active substances being selected. To improve the quality of information the EMA released the legal notice on the Implementation of Article 57(2) of Regulation (EC) No. 726/2004. This notice detailed that MAHs had to review their product information within XEVMPD and submit further mandatory information on their products by 31st December 2014. Another key change outlined in this guidance was the implementation of timelines for specific regulatory events. MAHs are required to submit information on new marketing authorisations within 15 calendar days of date of marketing authorisation approval. MAHs are also required to provide information following variation, transfer, renewal, suspension, revocation or withdrawal of the marketing authorisation information within 30 calendar days.
Following on from the 31st December deadline, MAHs are required to comply with the set guidelines. The improvement of data within XEVMPD is a process which will help to benefit users. The information provided to EudraVigilance will support key pharmacovigilance and regulatory activities such as:
- Coding of product information reported in adverse event case reports and helping to support and identify new safety concerns
- Helping to support regulatory decisions and actions such as referral procedures and the establishment of Periodic Safety Update Reports time frames and literature monitoring
- Calculating pharmacovigilance fees
- Helping to improve transparency and communication with the Agency’s stakeholders by providing access to safety data information on medicinal products.
2016 Introduction of International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP)
Following on from the Article 57(2) guidance, the next big change for EudraVigilance and XEVMPD is the implementation of ISO IDMP. The EMA plan to release the EU implementation guide by July 2016 and begin preparation for electronic submission of product information by Q1 2017.The ISO IDMP establishes data elements which will help with the identification and will assist with the exchange of information on medicines helping to simplify the exchange of information between competent authorities. It will also help in supporting healthcare authorities in the development of electronic health records. In order to be best prepared for the next transition phase it is crucial to comply with the timeframes and standards outlined in article (57)2. Due to the nature of data entered into XEVMPD, here at Panacea (www.panacea.im), our Regulatory Affairs team is responsible for our clients’ XEVMPD. Our Regulatory Affairs team will also receive input from our Pharmacovigilance team; for example to ensure all indications are coded using the correct MedDRA terms, helping to ensure our clients’ data is kept to the high standards required. Our Regulatory Affairs team is well trained in this area, having worked on XEVMPD since it became mandatory in 2012. Team members have attended the official EMA course, passed the required XEVMPD knowledge exam as well as completed the online XEVMPD e-learning course. In the upcoming months our RA team will be closely monitoring any information released on ISO IDMP as part of our weekly Regulatory Intelligence checks, to ensure that we are up to date and prepared for the next transition phase. If you have any questions or would like to get in touch for support with XEVMPD work please get in touch at Martha.Manini@panacea.im