RMMs and the Regulatory Environment

Introduction
International Conference on Harmonisation (ICH)
U.S. Food and Drug Administration (FDA)
European Medicines Agency (EMA)
Australian Therapeutic Goods Administration (TGA)
Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
Regulatory Perspectives on Changing Acceptance Levels and Specifications

Introduction

Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world, and in some cases, it has been necessary to work directly with the regulatory authorities in order to introduce a RMM as an alternative to an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorisation. However, there are also instances where a formal rapid method submission may not be necessary, and in order to develop an appropriate regulatory strategy for the implementation of RMMs, it is important to fully understand current regulatory expectations.

There exist a variety of different perspectives on RMM validation and submission strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities. For almost 10 years, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other global authorities have accepted and encouraged the use of RMMs, and have provided guidance on how the industry can apply these new technologies in the laboratory and manufacturing environments.

Unfortunately, many in the industry have been hesitant in implementing or even exploring the potential use of RMMs mainly due to a continued perception that the regulators either do not accept, understand or embrace RMM technologies. For example, some firms believe that the data coming from a rapid method will put their product at risk, that acceptance levels or specifications will not be met, or that there is no guidance on how to validate these new systems. These myths are simply not true and are not supported, especially in light of the myriad of enablers and guidances that the regulators have provided.

To assist you in navigating through all of the current regulatory information that is relevant to the validation and implementation of rapid methods, we will explore an array of guidances, strategies, presentations and publications from various regulatory agencies as well as quality initiatives from international harmonization committees.

Please click on one of the links at the top of this page to learn more about the RMM guidances, strategies, presentations and publications from various regulatory agencies as well as quality initiatives from international harmonization committees.

The implementation of RMMs represents significant progress toward the acceptance of microbiological PAT and QbD solutions for the industry, and is directly aligned with the expectations for pharmaceutical manufacturing, quality and operational excellence in the 21st Century. Whether a firm plans on satisfying the expectations of the FDA, EMA or any other regulatory agency, it is important to discuss your RMM qualification and implementation plans early in the design phase to ensure that the best strategy is agreed upon.

Developing a comprehensive regulatory strategy can be challenging, especially if your RMM will be implemented in a variety of worldwide markets. Our Consulting Team is available to assist with the design of an appropriate regulatory strategy, discuss options with your regulatory affairs and quality organizations, and act as your liaison during meetings with relevant agencies. Please visit our Consulting and Training Page for additional information.