EMA TO Open UP Article 57 Pharmacovigilance Database to Simplify Regulatory Changes
This article was originally published in SRA
The European Medicines Agency will soon open up its database to national competent authorities to give them access to information on the qualified person for pharmacovigilance (QPPVs) and the location of pharmacovigilance system master file (PSMF) for each drug authorized in the EU. Once this happens there will be no need for drug companies to submit variation applications with regard to changes on these fronts1.
At present, national competent authorities do not have access to this information held by the EMA in its Article 57 database (created under the EU pharmacovigilance legislation), so companies have to submit a Type 1A variation application to notify each national agency whenever changes are made to the QPPV's contact details or the PSMF location. Given the number of mergers and acquisitions that routinely take place in the pharmaceutical industry, the current requirement to submit a variation application every time such a change is made places an administrative burden on companies.
While access to information on QPPVs and PSMF location is expected to be rolled out to national competent authorities "in the coming weeks", the date from which companies will no longer have to submit variation applications is expected to be sometime early next year, said Dr Peter Arlett, head of EMA's pharmacovigilance department, who speaking at a conference organized by the Drug Information Association in London on QPPVs on Oct. 13 and 14.
To further the initiative, the EMA is developing the so-called "Article 57 Publication Dashboard Reports", which are reports containing a subset of information from the Article 57 database. These would be made available to national competent authorities though the Eudravigilance Data Analysis System, explained Ilaria Del Seppia, scientific administrator (data standardization and analytics) at the EMA's Business Data & Analytics Department, who also spoke at the conference.
After national competent authorities are allowed access to information on QPPVs and PSMF location, the EMA will put in place necessary training for its colleagues in national agencies through webinars "to make sure that it's a real access and not just a theoretical one," said Arlett. Following this, the EMA will allow a month or two for this new arrangement to "bed in" and it will then table the matter before the EMA's management board.
Arlett explained that the current requirement for variation applications will be done away with only after a formal decision is made to convey that national competent authorities should rely on access to the Article 57 database to get information on QPPVs and PSMF location. Arlett expects this decision to be made at the management board's meeting in December, but it may be announced and implemented later – either in the beginning of next year or by the first quarter of next year. "In terms of news [on when this will happen], we are hoping to deliver a Christmas present for the industry, subject to the management board's decision," he said.
Pharmacovigilance enquiries
The EU pharmacovigilance legislation requires each drug company to give an email address and telephone number where general members of the public can contact the company for any pharmacovigilance-related queries. Also, companies must make public the location of the PSMF.
As these details are already available in the Article 57 database, Del Seppia said the EMA is currently discussing the format in which this information can be made public. "This is something that we will make available on the agency's website and you [ie, drug companies] should be prepared to handle the enquiries that potentially will come [from the general public] following the publication [of this information]," she added.
A contract QPPV at the conference, however, raised concerns about making the PSMF's location public because for many small companies this would be the QPPV's home address. Del Seppia explained that the EMA had still not decided on the final format to implement this requirement, and that any concerns on this front should be raised at the EMA-industry meetings that are held routinely to support the implementation of the pharmacovigilance legislation.
Public Access To Article 57 Database
The long term vision is to open up the Article 57 database to the general public to allow people to find out whether a particular drug product authorized in one EU member state is also available in another state with the same or a different brand name. In cases where the same drug was not available, the database could help people find a product with the same active ingredients. "There is a lot of discussion on the [EU medicines] network on this at the moment," Arlett said, adding that there may be some action on this front in 2017.
In the short term, however, the EMA is following a phased approach to allow its stakeholders to access information in the Article 57 database. While the first phase focuses on providing national competent authorities with information on QPPVs and the PSMF location, the second phase would provide national agencies with "all information and data on medicinal products," said Del Seppia. The third phase would result in the EMA creating a dedicated webpage to proactively grant all stakeholders access to non-confidential information held in the database.
The Article 57 Database, which is also known as the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), is a repository of structured and quality assured information on all medicinal products authorized in the European Economic Area. The database was established in 2012 and it currently contains over 500,000 medicinal product entries.
References
1. Pharmacovigilance Programme – Update, Issue 5, Oct. 5, 2015, www.ema.europa.eu/docs/en_GB/document_library/Newsletter/2015/10/WC500195652.pdf