New! 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
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has also supported the implementation of RMMs, and several approvals have already been realized, including those for rapid sterility testing.
During the 2010 PDA 5th Annual Global Conference on Pharmaceutical Microbiology, Dr. Tsuguo Sasaki (GMP Expert, Office of Compliance and Standards) discussed his agency's policies and validation guidance that they follow with regard to RMMs.
The PMDA will work with companies in the development of RMM strategies for use in Japan. For example, in a number of cases, it may not be possible to detect microorganisms in stressed environments, such as purified water and reverse osmosis test samples. Therefore, it is hoped that more rapid and continuous monitoring methods are developed for microorganism detection in pharmaceutical-grade water systems.
Regardless of the technology, the PMDA will follow a similar strategy for reviewing RMM validation submissions as the U.S. FDA currently does. However, it would be appropriate to have the relevant conversations with the PMDA prior to initiating any RMM validation and implementation strategy.
The Japanese Pharmacopoeia has also developed chapters related to the validation of rapid methods. These include the following: