The European Medicines Agency (EMA)(3) recently announced a new pharmacovigilance legislation (1, 2), describing how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Considering the consequences on information management and business process, pharmaceutical companies have a very short timeline in which to adapt to and implement the initial phase. The attempt to define and establish the "Identification of Medicinal Product (IDMP)" standard(4-8) as a global harmonized electronic exchange format seems to be the biggest change in the regulatory registration process today. How agencies and pharmaceutical companies can address this new legislation along with the respective consequences for their data management is described in this article.
In the pharmaceutical industry, there is so far no established widespread standard for Document Management. The need and diversity of different regulatory processes resulted in several tailored applications to meet all kinds of scientific and operational requirements. With application and data complexity increasing, data gathering and reuse will become time-consuming. The issue is that the solutions themselves become increasingly sophisticated and complex with data more commonly held outside of any system due to a lack of interfaces. As a result, data entry is performed multiple times with all its drawbacks--including typing errors, spelling mistakes, or local variations creating data validation nightmares.
The new challenge started with the announcement of the European Medicines Agency on 1st July 2011 that the new EU pharmacovigilance legislation has to be supported from 2nd July 2012 for all authorized products in Europe. In this legislation, the EMA describes how to modernize its pharmacovigilance system, how to improve patient safety and how to supply health information to patients in a timely and efficient manner. To achieve this, the EMA is requesting the submission of medicinal product information (until 2012) and is going to update its Eudravigilance database, allowing the receipt of all individual case safety reports for Europe (until 2015). In this context, the EMA mandates a product dictionary and the provision of additional pharmacovigilance data which covers all adverse reactions, not only limited to serious ones.
It is obvious that all players in the regulatory environment, from authority to marketing authorization holders, from software vendors via CROs to Consultants, from APIs or Generics are affected by this regulation. It will be required to submit product information for all Europe authorized products as XEVPRM (eXtended EudraVigilance Product Report Message) along with the respective labeling documentation in local language as PDF. It must be noted that the new XEVMPD (eXtended Eudravigilance Medicinal Product Dictionary) exceeds in content and volume the actual existing EVMPD definition. Therefore, existing product information already available in the Eudravigilance database as EVMPD has to be updated.
A further challenge arises due to the comprehensive but also complex data model proposed. Pharmaceutical companies have to walk through and understand business and technical demands to fulfill regulatory requirements. This includes a basic understanding of data models and mandatory information, as well as new and existing record relations.
The continuous publication of regulatory guidance and standards creates a constant pressure on pharmaceutical companies, agencies and software vendors alike to comply with requested changes and updates in a timely manner. In combination with the looming deadline, all players are eager to find a quick, easy-to-use but flexible solution enabling them to comply with the latest regulations. However, the new pharmaceutical package is fairly complex and the introduction of IDMP has to be done carefully. The new medicinal product description itself is very detailed and all required information cannot be collected at once, if indeed it is available at all. One key business factor will be the development of a strategy on how to collect and prepare already existing regulatory information inside a company in a way that the following migration or transition process results in a harmonized data structure. Applications as well as data have to be maintained in this bidirectional data exchange.
A further implication of the new standard is the change in processes at agency and industry to deal with large amounts of data efficiently. Companies will produce a vast amount of data, very much dependent on the number of products registered, reports to be filed, and changes that require notification. Processes have to be defined to deal with the increasing demands on both sides of the gateway.
Different functions from various locations, departments or sites are involved during the process of data gathering and in the creation of reports based on the new pharmaceutical legislation. A lot of product information, their registration details and adverse reactions are collected and available in various databases scattered throughout the company. The harmonization of the product definition inside an organization is the first step for a new product understanding.There are a number of options available to establish a companywide product definition such as the internet and cloud computing or centralized and decentralized Document Management Systems. Wherever the data is entered or held, however the information is accessed, harmonization is increasingly important. Whichever approach will be taken by the company concerned, a harmonized and structured data standard of medicinal products is seen as essential.
In case of a product multi-data repository, a master repository is required to hold the main product dictionary, controlling access, and supporting data migration. A corporate network supporting the required interfaces remotely connects to the data source, collecting further information (for example) from subsidiaries entering data centrally. The information exchange between the satellite applications makes this solution more dependent on a secure IT infrastructure. The support and maintenance of such an environment is complex due to the number of software components and stakeholders involved. Each of the applications requires its own interface to the master repository that has to be specified, developed and maintained. Multiple data entry with all its challenges as well as data redundancies cannot be prevented.A single data repository which one can understand as a regulatory tracking database with integrated eCTD, pharmacovigilance and eDMS solution is another viable option for data handling. All information is gathered together in a single regulatory tracking database or regulatory master data dictionary that will be easier to validate and data redundancies can be avoided via a single data entry process. Because of its size and nature, building such a solution will be time-consuming and the migration of data from existing and established applications may become complex.
From the authors' perspective, the way of creating a single global repository will be the most promising one. It will offer a single data entry, less redundancy, and better data quality leading to improved reporting.
The new pharmaceutical package should be seen as a chance for the pharmaceutical industry to help globalize regulatory affairs information, increase information quality, and reduce information redundancy. The new pharmacovigilance legislation provides a platform for global data exchange and should not be seen as a burden, rather as a chance to improve information transparency, ultimately to the benefit of the patient. The added value in combining information from resources such as pharmacovigilance, product information, PSUR and in the future eCTD together in a single repository is in our view undisputed. Considering the timeframe for the introduction to XEVMPD is extremely short, first steps into the IDMP direction have to be taken now to harmonize the medicinal product dictionary, the next phase in regulatory affairs data management.
Editor's note: Life sciences executives interested in learning more about the new EMA EVMPD legislation and other key eRegulatory affairs topics should consider attending the eRA 2012 conference being held on March 20-21 in New Orleans. To learn more about the conference visit: http://eracon.org/.
Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from the University of Bath, England. Olaf is the Managing Director of EXTEDO Ltd. (United Kingdom), responsible for EXTEDO's expansion in Northern Europe. Before that, he worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on submission management. He trains regularly in all subjects related to the eCTD and presents on conferences in Europe. Email: email@example.com.
Gerhard Neurauter is Director of the Regulatory Competence Centre and product manager of EURSvalidator at EXTEDO (Germany). He has over 10 years of experience in eCTD and electronic submission management and he has been responsible for the conformity of EXTEDO tools regarding global and regional regulatory standards. Gerhard holds a PhD. in Analytical Chemistry from the University of Regensburg, Germany. Email: firstname.lastname@example.org.