FDA COMMITTEE APPROVES INTERNATIONAL HARMONIZATION PLAN

The FDA's Advisory Committee for Pharmaceutical Science has overwhelmingly approved the agency's strategy for developing new international harmonization approaches for drug development, but members expressed reservations about the development of new guidance to supplement the international standards.

The agency has been working on its "new vision for ensuring product quality" for the past three years. The project uses new guidance from the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) to improve product quality throughout a drug's lifetime. But the agency faces several challenges, including the difficulty in putting new concepts into practice and shouldering the heavy workload this represents while working with limited resources.

Specifically, the agency is using the ICH Q8, Q9 and Q10 guidances to drive this effort. The Q8 guidance addresses pharmaceutical development. In Q8, the agency is focusing on the Quality by Design principle where efficacy and safety standards are set based on a product's intended use. Q9 guides regulators in estimating risk and ensuring risk management is commensurate with the risk level. Q10 sets standards for industry's pharmaceutical quality systems.

Panel members did not want the agency to make a broad decision on whether additional FDA guidance was necessary to implement its harmonization initiative. Instead, the members urged the agency to only implement its own guidance if it determines that the ICH guidance is insufficient.