DIP Methodology
The DIP Methodology Technical Working Group was established in January 2011 to identify challenges in applying the DIP Methodology under the Guidelines that came into effect on January 1, 2010 and to develop workable solutions to ensure that the Board's objective in adopting the DIP Methodology is met.
The working group consisted of three representatives of the pharmaceutical industry, two representatives of the biotechnology industry, one representative of the generic pharmaceutical industry, and four members of Board Staff.
The final report of the working group was presented to the Board at its quarterly meeting on March 4, 2011. The Board has decided to implement the recommendations of the Working Group on a pilot basis until December 31, 2011, at which time it will be evaluated.
The guides and templates to be used to implement the new Simplified and Regular DIP Methodology can be found below.