Good Regulatory Practice

February 4th, 2010

Good Practice for Regulatory Affairs has not fully been defined. In industry, it is often incorporated into the Quality Management System and from there Regulatory Standard Operating Procedures (SOPs) can be used to standardise submissions, responses, health authority interactions and to create a more holistic, speedier and compliant approach. SOPs can be used as a platform from which legislation is interpreted for the company, to influence company decisions and outputs and to drive the standard of interface with the authority. Indeed “Good Regulatory Practice” is integrated into Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and the ISO 9000 series. I believe there is a lot more scope for this area to evolve further independently, as Regulatory grows and becomes more complex and as companies realise the impact it has on commercial success.