Harmonizing regulations at ICH (International Conference on Harmonization) prospectively before any exist is a lot easier than retrospectively, where three different sets of regulations have to be harmonized into a single whole.
When dealing with regulatory agencies and the public it is always best to try not to bury issues or problems, but to be transparent with them and discuss how you intend to deal with them.
We have GCPs, GLPs, GMPs and others. Why do we not have GRRPs (Good Regulatory Review Practices) for how the regulators have to do their jobs in reviewing your applications?
Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).
