In a complex regulatory environment, change control is a challenge and its success is hindered by the structure and operations of the various organizational functions involved. To address this, defining an effective operating model and a regulatory ecosystem that encompasses people, process, data, and technology can ensure that regulatory affairs remains an asset to the growth of the business.
Pharmaceutical companies are under significant pressure to grow their business while managing increasing regulatory complexity and competition. If Regulatory Affairs (RA) can enable business growth over and above ensuring regulatory compliance, RA would be considered a corporate asset instead of a cost center, leading to overall improvement in productivity, reduced time to market, all the while generating higher levels of conformance. Today’s organization landscape is hostile to RA’s mission, and actually hinders its enterprise value proposition, leading to an environment of chaos, instead of a harmonious ecosystem of people, process, data and technology (see Figure 1).
Consider the supply chain: products must be manufactured, packaged, and delivered in a cost-effective and efficient manner that is in conformance with the product license for each market. In addition, the company must provide a return on investment and transparency to stakeholders while maximizing effectiveness. Further, global products have complex supply networks, and that can lead to situations where a manufacturing site may be unaware of the final market destination for each batch produced, so it may not meet the Marketing Authorization (MA) requirements. Moving to contract manufacturing organizations only adds complexity to managing regulatory conformance, as many agreements are structured with reductions in cost, not maintenance of MA compliance, as the primary driver.
In order to ensure products sent to a market are manufactured, packaged, and delivered in line with the relevant Health Authority (HA) regulatory requirements, an effective governance structure and change-control process must exist to manage product change. Governance across all functions will ensure that strategies are clear and balanced – meeting both the compliance and financial needs of the company. Individual site change-control processes and systems are insufficient to ensure MA conformance. Instead, product change must be considered globally, across commercial, regulatory, supply chain, and quality functions supporting that product.
Change management in the regulatory ecosystem
Enterprise product change management is the backbone of a regulatory ecosystem that is an asset to internal functions, external partners, and HAs (see Figure 2). An effective regulatory ecosystem will ensure products are released in compliance with the relevant market regulatory requirements or submission commitments in a timely manner. Due to the span of change control across the organization, its regulatory complexity, and time, a new sustainable operating model is required to ensure compliance and contain costs. When gaps are detected at release or by HAs, this increases the risk to patients, increases cost (rework, fines, delayed revenue), and can damage the company’s reputation.
HAs recognize this risk and are enacting legislation that is transforming how product information is managed, including eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), identification of medicinal products (IDMP), unique device identification (UDI), European Medicines Agency (EMA) Annex 16, and others. For XEVMPD and IDMP, an effective product-change-management model is required to be able to supply HA updates within 15-30 days of approval. In planning for the new EMA Annex 16, an EU contract manufacturer for one of our clients has stated they would not release product without access to the current cumulative marketing authorization. Excerpts from the current draft of Annex 16 below:
- The Annex has been revised to reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies
- If the Qualified Person (QP) is responsible for confirming compliance of those operations with the relevant marketing authorization then it is expected that the QP has access to the necessary details of the marketing authorization to facilitate declaration of compliance
Pressures, from internal growth to regulatory requirements and product complexity, will only continue to increase. Therefore, the solution—the people, processes, data, and technology of the regulatory ecosystem—needs to be agile to maintain compliance and cost effectiveness. Addressing the full ecosystem ensures its effectiveness today, and in the future, through embedded mechanisms that deliver continuous improvement as well as broader enterprise insight.
Establishing the regulatory ecosystem
In our experience, companies already have high-caliber talent, and so the first step is to define an effective operating model for organizing existing human resources. The operating model provides a foundation to build on, including the framework for the process. Aligning people with a well-defined operating model creates role clarity, effective processes, and a higher level of collaboration—core elements of a best-in-class organization.
The operating model also provides transparency to internal and external partners. Accomplishing visibility can be challenging due to factors such as competing stakeholder priorities, changing regulatory requirements, compounding changes for a product, and HA timing requirements pre- and post-approval. It can be further complicated by decisions made by local operating companies to bundle changes, remove/redact sections, add local content, and translate documents.
Information used and created by the process must be trusted. An organization quickly loses its value and reputation with partners when it provides questionable information. When this occurs, it creates additional work and time to validate information to ensure quality decisions. The ability to achieve and sustain effective processes is often restricted by the current commercial systems of record. Over time this results in a gap between effective processes and what systems can enable (see Figure 3).
People want to be efficient and are in their roles because they are passionate about providing novel strategies and value-added deliverables. However, systems can provide barriers, and people may resort to workarounds, including the use of spreadsheets, which over time leads to data collected in both systems of record and an after-the-fact archive. Systems of record are not designed with the end-to-end process in mind, only a particular portion of it. Further, even for that portion of the process, they often have complicated interfaces, weak analytics, and limited or non-existent ability to interact with other systems of record required to execute the end-to-end process.
Currently, there is no single end-to-end platform for regulatory on the market. There is, however, a proven technology solution that can accelerate regulatory activities by taking a process-based view and embracing smart technologies.
A System of EngagementTM layer sits on top of existing systems of record and orchestrates business processes, using a thin layer of technology in a flexible and adaptable way as the business evolves. With built-in capabilities for automation, mobility, social collaboration and analytics, it will dramatically accelerate the efficiency and effectiveness of regulatory organizations and significantly reduce regulatory compliance failures.
In setting up the regulatory function as an effective regulatory ecosystem, we can enable enterprise and individual success (see Figure 4). We provide clear roles and responsibilities originating from an effective operating model. Processes focus on value-added activities, in which wasted effort is eliminated, and continuous improvement is embedded, based on facts that drive sustainable change.Technology provides a single cumulative view of all of regulatory and documentation with the associated HA status, with a metric- and dashboard-driven view with actionable real-time and predictive insights. Further, the data and analytics provides automated “listeners” that furnish rapid global regulatory and competitive intelligence, with winning strategies shared and lessons learned from mining existing internal and public information. Finally, using smart technology in the operational framework and leveraging automation, we can achieve the ultimate goal of increasing productivity, reducing time to market, and enabling high conformance levels. Change-control may not be any less complex, but it is no longer an enemy of effective business performance.