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New Generic Stability Requirements

After much delay, FDA just released the new guidance on the stability requirements to file and obtain approval of a generic drug product and API under 505j. The new requirements bring ANDAs closer in line with NDAs and ICH. The new requirements as summarized in the Guidance are:

  1. Submit data from three pilot scale batches or two pilot batches and one small scale batch. If the size of the pilot does not follow ICH recommendations, the applicant should provide a justification.
  2. At the time of submission, provide 6 months of data that include accelerated and long-term conditions. FDA recommends following ICH with respect to utilization of intermediate conditions to support shelf-life.
  3. Use multiple lots of drug substance as appropriate.
  4. Manufacture and package the drug product using principles that are representative of the commercial process.
  5. Provide a fully packaged primary exhibit batch.
  6. Use three batches when using bracketing and matrixing designs under ICH Q1D.
  7. Provide statistical analysis of the data as appropriate, in accordance with ICH Q1E, Appendix A.

The Office of Generic Drugs had said at the 2011 GPhA Fall Technical Conference that the new Guidance would require 12 months of room temperature data at the time of submission (as required for NDA’s) but this Guidance states just 6 months data is needed. Still, the new requirements are a big increase over the historical requirement of one batch at 3 months accelerated and 3 months room temperature. The new requirements will increase the cost for a new generic.

Importantly, this new guidance adds three months to the development timeline.