(Source: Source Wire 2014-5-22）
Many firms in the European pharmaceutical industry are not yet ready for the latest requirements of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) mandate, according to new research from life sciences outsourcing and consulting services specialist ProductLife Group.
The research took place at a roundtable designed to better understand the pharmaceutical industry’s readiness to manage the latest requirements of the XEVMPD mandate, with more than two-thirds of respondents (68 percent) admitting they have either not started the process of preparing for the XEVMPD, or are only in the early stages of addressing requirements.
The main reason given for this lack of preparation was resources, with 59 percent of respondents saying that lacked the resource to meet the XEVMPD deadline, with few regulatory and safety leaders having the time to carefully study the extensive information contained in the European Medicines Agency’s (EMA’s) guidance.
“While we can all relate to a lack of resource, firms simply have to find a way of meeting the XEVMPD deadline – it is non-negotiable and the consequences of not doing so are far-reaching,” said Erick Gaussens, chief scientific officer, ProductLife Group. “While the processes around updating the XEVMPD data are fairly straightforward, the problem with maintaining the XEVMPD data is that the processes involved aren’t isolated, yet the data they manipulate can be stored in different systems and used by different people. This needs to be understood and managed.”
The XEVMPD requirements constitute a major change in European drug law, with firms required to provide detailed structured data for all human medicinal products authorised in EU/EEA to the XEVMPD. Data required includes detailed information on administrative, product-related and substance-related data.
The role of local affiliate companies in managing XEVMPD requirements were also sources of great concern for research respondents. 32 percent identified lack of local affiliate awareness, while 46% identified limited affiliate resource capacity to process XEVMPD submissions as a significant challenge. With regard to data management, concerns ranged from different naming conventions in each country (32 per cent) to information in local SmPCs not being up-to-date or made available to the central headquarters organisation (18 percent).
A majority of respondents (59 percent) are choosing the EVWeb to submit data, as opposed to just 23 percent using the Gateway. A further 14 per cent are unsure while 4 per cent will use a customised or in-house solution that uses the EV POST.
“The fact that 14 percent of respondents do not yet know which solution they will use to submit data to the XEVMPD, is worrying to say the least,” said Andrew Marr, PhD, Managing Director, Marr Consultancy and chair of the roundtable. “People aren’t sure which foot to put forward in moving their companies ahead with the XEVMPD but it’s a decision that needs to be made sooner rather than later.”
ProductLife Group (PLG) engaged with more than 20 regulatory affairs and safety leaders to pose a series of key questions, with responses coming solely from people with responsibility for managing the XEVMPD in companies across Europe. A select group of regulatory and pharmacovigilance heads were then brought together for a roundtable debate on the research, with discussion led by XEVMPD expert Andrew Marr; PLG’s chief scientific officer Erick Gaussens; and Philippe Banes, PLG’s head of regulatory operations.