Regulatory Policies and Expectations

Click on the Following Regulatory Pages:
New! Annex 1 Revision Encourages the use of Rapid Methods
Recent Policy Changes for Advanced Therapy Medicinal Products (ATMP, gene and cell therapy)
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. In many cases, it is advantageous to work directly with regulatory authorities to fully understand their expectations for validation and submission requirements.

To assist the industry in considering appropriate strategies for the validation and use of RMMs, 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. A number of guidance documents and policy changes have been developed to assist the industry in implementing rapid and alternative technologies in the laboratory and manufacturing environments. Using the links at the top of this page, you can navigate to comprehensive summaries for the most relevant regulatory guidelines.

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.