Data, data and more data. Pharmaceutical companies depend ondata to bring products to market, but companies struggle to cohesively andcoherently manage all that data and all that information. In response,regulatory information management (RIM) has come to the fore, and companies arerecognizing its value—at least in terms of how companies communicate withregulatory authorities. But exactly what RIM is and how it fits into thebroader scheme of managing products and submissions is perhaps less wellunderstood.
RIM is the method of bringing together all of the pieces ofinformation and data that tell a product's complete story. But it's not usedsimply to collect information or have a nice picture of data; rather, thepurpose is to help companies achieve two things: to stay in compliance withhealth authorities' requirements and to make well-considered commercialdecisions around a product and the portfolio.
Drivers to betteroversight
A few years ago, the concept of regulatory tracking appearedon companies' radars, but there wasn't necessarily a clear understanding as towhy tracking was a good idea. With changes in the regulatory and commerciallandscapes, companies realize they need a better way to track—and, moreimportantly, manage—critical regulatory information.
First, the need for better oversight of regulatoryinformation must be seen in the context of the regulatory authorities' sharpfocus on safety. Health authorities have become far more risk averse, andcompanies need to demonstrate compliance with the regulations. With that comesa whole raft of data and the need to track that data. Perhaps the mostprominent example of legislation designed to provide agencies withmore-extensive pharmacovigilance information is the European Medicines Agency'sEudraVigilance Medicinal Product Dictionary (EVMPD) mandate. The EVMPD is theEuropean Medicines Agency's central database of what products are registeredwhere. On July 1, 2011, the agency issued a legal notice based onpharmacovigilance legislation requiring that every company submit EVMPD data byJuly 2, 2012, for its every product authorized in the European Union.
This is a mandate with wide-reaching implications. Itrequires that marketing authorization holders send to the European MedicinesAgency all information on products and substances that would ordinarily havebeen stored and gathered by the individual market companies, or affiliates, andthat would therefore not be in one place. Similar information is needed for theU.S. Structured Product Labeling listings and registrations, though it's lesscomplex for companies to navigate, because the United States is a singleregulatory market—meaning, companies don't have alternative versions ofproducts, or translations of product names, or labels they have to produce fordealing with the 27-member European Union.
Other drivers have been the economic climate and companies'realization that they need to do more with less. Very few pharma companies havebeen untouched by the economic climate as it is today; most of them haveeliminated redundancies, and they have not been recruiting, so they have tomanage differently both their businesses and the information that stems fromwhat they do. With fewer resources to achieve their objectives, companies arelooking to technologies and improved processes instead.
So while regulations require that companies have bettercontrol of their regulatory information, smart companies are recognizing theopportunity for using that information to their own advantage—for example, tomake decisions about the portfolio and their future direction.
Moving on
In its early days, RIM was simply seen as a way forcompanies to track what was happening with their products. Today, however, mostbusiness leaders are looking to RIM to give them clearer oversight of thecompany's products, as well as insight into what to do next. They want not onlyto know where information is held globally, but also to be able to connect thatwith data and information coming from other sources. In other words, they don'twant simply a static line of data; they want a three-dimensional model thatgives them a complete picture of everything that can be done with a particularproduct.
More than that, business leaders want to be able to seethemes and recognize trends in regions, not by looking at just one product butacross a portfolio to help them make decisions farther down the line.
By way of example, most large or mid-tier pharma companies havenumerous products registered around the world in different ways, underdifferent names and in various formulations. When a new product is about to hitthe market, commercial groups will want to know about specific markets so as todetermine how best to promote, or even establish, the new product in aparticular market. Commercial teams might ask regulatory affairs whether theycan market the product in a particular country—from a legal and regulatorystandpoint. But without access to information about existing products on thosemarkets, it would be impossible to give the commercial teams the informationthey need to make a well-considered decision.
From a purely commercial standpoint, RIM is probably themost important way of knowing what, where and when a company can market as wellas how future markets are going to look, because the knowledge will be based oninformation collected about the products a company has in various markets.
Quite simply, regulatory information puts more informationat a company's disposal so decision makers are better placed to decide how tomove forward.
Challenges toimplementation
Companies that have long-established products on the marketface challenges to comprehensive RIM because trying to piece together thosehistories could be overwhelming. Companies have to decide whether it's worthcollating information on products that might have been on the market since,say, the 1970s.
It's quite understandable that companies might decide theywill start implementing regulatory information management only from the pastfive years, for example. So the first decision that companies will need to makeregards where to start—and that decision will depend on where that company isin its own history and where its products are in their life cycles.
Equally, companies need thorough understanding of how theycurrently gather and manage information. For example, do they have centralizedor decentralized points of control? Where is the information held? And whomaintains it? Sometimes companies decide to acquire a RIM system without evenconsidering who will be using it and who will be updating it. Yet those are thetwo criteria most important to operating a RIM system: (1) knowing who thecustomers are and what they'll try to use it for and (2) who is going to keepit current.
At the start of a regulatory information management project,companies' biggest challenges are to move into a single, central repository allof the information that exists in databases and spreadsheets and in solutionsacross the enterprise and to use the same terminology for the same data.
Another difficulty companies face is that because RIM needsto be implemented as an internal project, it lacks the standards available formanaging submissions. Moreover, too few comprehensive RIM solutions have beenimplemented in the industry as yet for best practices to evolve. The reality isthat each company has its own way of viewing RIM—and therefore its own needs.Some might take a project management approach; others form a pharmacovigilanceperspective; and still others might be most keenly focused on registrationtracking.
There's a trend toward greater standardization of productinformation. For example, Identification of Medicinal Products (IDMP) is anInternational Organization for Standardization standard that will ultimatelyreplace the EVMPD in 2015. IDMP has at its root the Common Product Model, whichis also part of the FDA Structured Product Labeling (SPL) and Individual CaseSafety Reports (ICSR) for adverse event reporting, and which will also beintegral to the forthcoming electronic Common Technical Document (eCTD) version4.0, which is modeled on Regulated Product Submissions, the Health Level SevenInternational (HL7) standard in development to support the U.S. Food and DrugAdministration's broad regulatory commitments.
Nevertheless, even though such standards would build greaterstructure into the overall management of regulatory information, because of thediffering needs of companies—small, large, virtual and so forth—the way a RIMsolution is maintained will vary from company to company.
Consolidation
Regulatory information management can touch every aspect ofa company's business—from product management, which keeps track of whatproducts are on the market and where, licensing status and whether safetyupdate reports are due, to submission management, which is involved with wherea company's products are registered, where it is waiting for things to happen,what agency correspondence has been exchanged and requires response and soforth.
Greater opportunities to have information stored in andshared from a central repository—thanks to the development of virtual privatenetworks and the cloud—make RIM more tangible for dispersed organizations, andgrowing regulatory submission requirements presage the need for improvements inthe management of regulatory information. As these factors escalate and ascompanies become more aware of the potential for better managing theirpipelines around the globe for commercial gain, so too will the demand for—andthe levels of sophistication of—RIM solutions.
Gillian King is headof global consulting and global professional services at CSC Life Sciences, andhas more than a decade of regulatory experience in the life sciences industry.Joel Finkle is senior strategist of regulatory informatics at CSC Life Sciencesand a member of the Health Level Seven International Regulated ClinicalResearch Information Management working group that is developing Regulated ProductSubmission standards.
