Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

On May 2012, CBER published their "Strategic Plan for Regulatory Scince and Research 2012 - 2016". This document includes the following regulatory science and research strategic goals:

1. Increase the nation’s preparedness to address threats as a result of terrorism and pandemic influenza and emerging infectious diseases
2. Improve global public health through international collaboration including research and information sharing.
3. Enhance the ability of advanced science and technology to facilitate development of safe and effective biological products.
4. Ensure the safety of biological products.
5. Enhance research excellence and accountability.

In part 1 "Increase the nation’s preparedness to address threats as a result of terrorism and pandemic influenza and emerging infectious diseases" as well as in part 3 "Enhance the ability of advanced science and technology to facilitate development of safe and effective biological products" CBER claim "Rapid Pathogen Detection", rapid screening for pathogenin cellulary products and "Developing highly sensitive, rapid methods to test the sterility of biological products" as a part of their strategies.

In addition to the FDA activities and statements during the last month (see GMP news from 8 August 2011, 9 September 2011, 23 May 2012 and from 27 June 2012 and the previous News in this newsletter) this statement will be a further step of the authorities to support the implementation of Rapid Microbiological Methods as alternative to compendial methods.

Compiled by
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)