Regulatory operations, ethics and the global landscape

Feature ArticlesFeature Articles | 02 April 2020 | Citation

Feature articles throughout March covered a variety of topics by leading regulatory experts, including underlying root causes of serious and continuing noncompliance and how professionalism, integrity and ethics can enhance communication between regulatory and cross-functional teams. Other key topics included the progression of regulatory intelligence and strategy to foster the evolving landscape, how the role of regulatory operations professionals is evolving and understanding the electronic Common Technical Document (eCTD) submission process for effective communication with health authorities.


Serious noncompliance behaviors include enrolling participants into drug trials who do not meet inclusion criteria, failing to report serious adverse events or conducting a clinical trial without review and approval by an Institutional Review Board (IRB). Research and ethics experts, James M. DuBois and Alison L. Antes, identify some root causes of serious and continuing noncompliance and describe a first-of-its-kind research program developed to remediate noncompliance. In Responding to Serious or Persistent Noncompliance, the authors offer regulatory professionals a training referral option and a variety of issues to consider when developing action plans to address serious noncompliance.

Over the last 120 years, more than 200 laws have been passed in the US supporting FDA enforcement, creating one of the world’s most comprehensive networks for public health and consumer protection. Regulations overseeing medical products have expanded greatly since the mid-1900s and more products involve oversight from additional government agencies. In Key Concepts to Enhance Regulatory Communication and Ethics in the Current Environment, regulatory manager, Stephanie Markey, discusses the current regulatory environment, presents several ideas for enhancing communication among regulatory and cross-functional teams and cites RAPS core values for maintaining regulatory ethics.

Submission Strategies

With the transition from paper to electronic submissions and the use of eCTDs, the push toward global harmonization in regulatory review has been an important milestone for the future of pharmaceuticals. While this technical change has improved the ease of review and access to archived information and document navigation, it also created new considerations for effective communication, namely understanding the technical aspects required to create a clear and comprehensive submission. Senior regulatory associate, Cedar Smith, discusses the benefits of understanding the role of regulatory operations and facilitating proper internal team communication with regulatory affairs to support efficient and clear communication with health authorities through the eCTD submission process. Improving Communication with Health Authorities Throughout the eCTD Submission Process highlights steps and procedures to improve both understanding and carrying out the submissions process.

In the US, companies are required to have specific documents authenticated before they are able sell products in international markets and depending on the destination country for the product(s), the authentication process is referred to as either “apostille” or “legalization.” While the apostille process is straightforward, legalization procedures are complex and subject to modification with limited notification. Legal expert, David L. Watt, explains the document authentication process with a focus on corporate documents in Apostille and Consular Legalization: Critically Important, Often Overlooked. The author clarifies the issue with a series of case studies.

Companies progressing through the regulatory process may ultimately seek approval for their product in both the US and Europe. As part of that process, they may have to face either an FDA Advisory Committee (ADCOM) meeting in the US or a Committee for Medicinal Products for Human Use (CHMP) Oral Explanation (OE) meeting in Europe. In Preparing for High-Stakes Regulatory Meetings in the US and Europe, scientific and communication experts Bert Regeer and Kate Dion provide regulatory professionals with an understanding of the specifics of FDA ADCOM and CHMP OE meetings. The authors outline key guiding principles to help regulatory teams more effectively structure their preparation timelines, bring focus to their pre-meeting work and ensure they perform well on meeting day.

Global Landscape

Orphan medicinal products (OMPs) are products indicated for treatment of rare or life-threatening conditions affecting a very small proportion of the population. The rationale for the concept of orphan designation was to encourage development of medicinal products for rare diseases which may not always generate a high enough commercial value for a sponsor to develop and market without support or monetary incentives. In Global Orphan Drug Regulation, regulatory consultant, Julie Watchorn, explains the criteria for and regulation of orphan designation in major global markets and outlines the application process and incentives for orphan designation globally.

Regulatory operations professionals in the medical device industry have reached a crossroads. Mounting challenges due to globalization, increased supply chain complexity and patient safety have made regulatory teams far more strategic to their organizations. Technology strategist, Terri Howard, highlights the shift taking shape in the medical device and diagnostics industry in How the Role of Regulatory Operations Professionals Will Evolve and defines regulatory professionals’ increased impact on business decision-making as a result of new global regulations that require a complete regulatory transformation. This is the second in a two-part series on the evolving role of regulatory operations professionals.

As the regulatory landscape continues to evolve, it is essential for the pharmaceutical and medical device industry to develop adequate systems to ensure strategy and intelligence is embedded into the product lifecycle for new products, as well as to ensure legacy products already on the market continue to meet the expectations of today’s regulations. Executive director, Darin S. Oppenheimer, et al,  discuss the opportunities and challenges of creating and maintaining a regulatory intelligence program across regulated industry in Adopting Regulatory Intelligence Strategies to Foster the Evolving Landscape. The authors suggest a regulatory framework and best practice considerations to implement intelligence strategies in lieu of a standardized approach or framework.

What’s coming in April?

April articles will focus on a variety of topics related to the implementation of EU MDR and EU IVDR, including the Eudamed delay and the impact to transparency for clinical investigations, the changing regulatory landscape in Europe and potential struggles for manufacturers, the future of submissions under the EU MDR and ISO 10993-18 and the implementation of a pharmaceutical regulatory operations outsourcing project from the business and vendor perspectives. Look for these topics and more throughout April.

June Call for Articles

Regulatory Focus tackles nutrition in health and disease management in June. The submission deadline is 4 May. To contribute to June or suggest a topic, contact


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