Regulatory Support Models
Regulatory support models are used in markets around the world to provide drugmakers with the help needed for drug product development and improvement in a constantly evolving regulatory landscape.
Gaining approval of a drug marketing application requires that the drugmakers provide a solid regulatory submission that demonstrates control of all aspects of the manufacture, testing, storage and distribution of the drug product. After marketing approval has been obtained, the manufacturer continues to update and maintain its marketing application to reflect any process and control changes, as well as keep up to date with regulatory requirements and expectations.
The contribution of the container closure and delivery system to the overall agency assessment of a regulatory submission package can be quite substantial. This is especially true for parenteral drugs, where primary components of the container closure systems are typically considered by regulatory agencies to be significant because of the inherent contact with the drug product and its function to maintain container closure integrity to protect the drug’s purity. In many cases, pharmaceutical and medical device component manufacturers can play a key role in assisting drugmakers in developing a stronger regulatory submission package for regulatory applications, thus assisting with the success of marketing applications.
Drugmakers increasingly operate on a global basis, so it is critical that delivery system and pharmaceutical and device component suppliers structure regulatory customer support to include major global regulatory markets. Taking a global approach can simplify the manufacturer’s regulatory submission plans by providing documentation that can be applied in multiple markets. When this approach is not practical, a globally focused regulatory department can also provide customized documentation to assure that the drugmaker receives the support needed for particular submissions.
For example, suppliers’ Regulatory Affairs departments can maintain Drug Master Files in the U.S. and Canada to provide those regulatory agencies with proprietary information on their components. The confidential information filed with these agencies should include: formulation information, equipment qualification and validation, description of the manufacturing process, analytical test methods and reports, other cGMP information and post-processing. For drugmakers that intend to file applications outside of the U.S. and Canada, component suppliers can provide submission templates that drug manufacturers can insert into their drug applications. This approach ensures that the global submission strategy is supported in a comprehensive manner.
To provide a significant regulatory benefit, suppliers should gain understanding of a pharmaceutical manufacturer’s business and technical drivers. It is critical that suppliers understand the drugmaker’s requirements to tailor the supporting data package(s) for its drug product applications. For instance, there are different expectations for container closure components versus individual constituent parts of combination products such as a delivery device packaged with a drug. Another example would be the level of information required at an early clinical phase, which may not be the same as for a marketing application. The critical supplier’s regulatory support function should adapt its output to the specific needs of the manufacturer’s drug product, relative to where it exists in its lifecycle.
Component suppliers should employ regulatory models that involve strategic understanding of the drugmaker’s regulatory needs. Working together enables a more germane approach to generating information that is designed to provide maximum benefit to the drug manufacturer.
Strategic regulatory alignment also requires that a productive rapport be maintained with regulatory agencies around the world. Maintaining an awareness of agency thinking and engaging in productive dialogue can provide regulatory departments with the knowledge to further enhance the quality of their regulatory information. Once again, this translates into more effective support for regulatory submissions.
Proactive Regulatory Awareness
Proactive support requires more than providing responses to requests. It is essential that a supplier maintain an ongoing awareness of emerging regulatory trends in major global markets. By adopting this forward-looking approach and combining it with regulatory expertise and strategic planning, a supplier’s regulatory department can assist drugmakers by providing proactive support.
Regulatory Affairs departments should monitor global regulatory trends to provide drugmakers with notice of potential regulatory changes that can affect their products. These trends include proposed changes to regulations, guidances and compendia, and provide proactive updates to support regulatory needs. By adopting this approach, component suppliers can provide support to existing and potential new drug manufacturers by ensuring that their products will meet changing regulatory expectations.
To ensure an optimal drug product, drugmakers should receive strategic support throughout all stages of a drug product’s life cycle, including drug discovery, development and all phases of clinical studies, as well as commercial and post-commercial activities. Comprehensive regulatory expertise and submission support should span all of these phases of a drug’s lifecycle. This comprehensive approach becomes especially important as the manufacturer progresses from Phase III development into marketing approval, and beyond to post-approval maintenance of their applications and licenses.
The regulatory landscape is constantly evolving. Pharmaceutical manufacturers and critical suppliers must continue to evolve to meet these changes. In addition to monitoring and adapting to relevant regulatory changes, it is also important that the supplier’s regulatory department monitor its own processes and the resulting manufacturer outcomes. As information is collected, the regulatory unit should use these data to articulate an understanding of its processes in order to foster an environment where continuous improvement is encouraged and expected.
A global regulatory affairs model should include a focus on continuous improvement, relying on input from a variety of sources, including:
- Regulations, guidances, etc.
- Regulatory meetings and interaction at conferences
- Pharmaceutical manufacturer input, collaboration, feedback
- Evaluation of emerging regulatory trends in major global markets
Global regulatory affairs models used by component and device suppliers should be designed to create a strategic approach to supporting drugmakers. By incorporating the elements of global focus, strategic alignment, proactive regulatory awareness, lifecycle support and continuous improvement, these models can provide drugmakers with the information needed to provide global regulatory agencies with strong regulatory submission packages for their drug product applications and licenses.
Regulatory affairs models must evolve along with the changing needs and expectations from regulatory agencies and drugmakers around the world. This regulatory support model is an integral part of the value provided to pharmaceutical companies.
Debbie Thomas is global vice president, Regulatory Affairs at West Pharmaceutical Services. Steve LoCastro is director, Regulatory Affairs at West. For more information about this article, please contact firstname.lastname@example.org.