Global Regulatory Town Hall - Annual Meeting 2015“It’s a great time to be a regulator!” kicked off the first-ever Global Regulatory Town Hall at the ISPE 2015 Annual Meeting.  The attendees received the chance to hear directly from 10 FDA and international regulators in a question-and-answer style forum.  The panel of regulators from around the world addressed the industry’s most pressing issues, including:

  • Drug Shortages
  • Increased Transparency
  • Data Integrity
  • Quality Metrics
  • Risk-Based Streamlining

Questions surrounding data integrity centered on computational models, and whether companies should implement a mathematical formula to ensure integrity or one that is physically-based. The answer to this question focused on utilizing the method that works the best for each individual company but stressed with the computational models, the end result will need to demonstrate the math used to get the submitted formula.

Each regulator explained the state of Quality Metrics with the discussion converging around the approach Europe and Japan are taking in implementing a similar program.  Europe is currently engaging in discussions with the FDA and processing the information in relation to where they are now and where they want to be.  As for Japan, they’re taking a risk assessment approach with the PDMA quantifying the risk assessment.

Risk based versus risk justified continues to be biggest problem in relation to Quality Metrics. The FDA regulators commented on there being two different Quality Metrics methodologies of accessing the same information but the concern comes in when there is a pre-desired outcome and the risk assessment is used to get there.  The concern arises from companies cutting too deeply with an end result of adding more risk versus streamlining their processes.

The interactive forum continued with the focus shifting towards international regulations surrounding PIC/S and the PRIME Program sponsored by the EMA.

PIC/S has formed a number of different working groups to set the scene for GMPs.  Some of the working groups include Good Distribution Practices, Blood Tissues, Advanced Therapy Products, Data Integrity, Controlling Cross-Contamination and Good Clinical Practices.  A few of the benefits and initiatives that will come out of the working groups include:

  • PIC/S Inspector Academy – an area for all of the global inspectors to have access to information and training
  • Joint VISA Program –  will allow inspectors to travel to other regions and see how other inspectors are conducting inspections
  • Annual seminars to drive training for inspectors
  • Harmonization of classification

The discussion of the PRIME program sponsored by the EMA created a great buzz from the audience.  This program is slated to launch during the first quarter of 2016  focusing on providing enhanced regulatory support for drugs in development that meet unmet medical needs.  The PRIME program has been compared to the FDA’s accelerated approval programs, which help fast-track drugs through the regulatory process that appear to have a significant impact on public health.

Learn more about the PRIME program by reviewing the reflection paper published by the EMA.