FDA Publishes New Draft Guidance Essentially Clarifying that the Human Drug GMP Guidelines (ICH Q7) Apply to the Manufacture of Veterinary Active Pharmaceutical Ingredients

FDA has published new draft guidance on the safe manufacturing of active pharmaceutical ingredients (APIs) for animal drugs. Following a consultation period, it is also expected to be implemented in Japan, the EU, and the UK. Chris Fanelli, Dr. Chris Boyle, and Dan Roberts discuss what the new guidance means for animal drug manufacturers.

On January 24, 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance outlining the agency’s current thinking on the manufacture of veterinary active pharmaceutical ingredients (API). This guidance, titled “Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products,” was developed by the Veterinary International Conference on Harmonization (VICH), a trilateral (US-EU-Japan) program aimed at harmonizing technical requirements for veterinary product registration. This new draft guidance largely adopts principles and practices set forth in ICH Q7 (Good Manufacturing Practice for the Manufacture of Active Pharmaceutical Ingredients) to the animal drug context and reflects FDA’s broader move toward harmonization of regulatory standards and requirements across the numerous products the agency regulates. Indeed, we have previously written on the expansion of the Mutual Recognition Agreement (MRA) to animal drugs.

The draft guidance sets forth a comprehensive framework designed to ensure the safety, efficacy, and quality of medications developed for animals. Accordingly, the draft guidance describes FDA’s (and other global health authorities’) current good manufacturing practice (GMP) expectations in the areas of facility design, equipment validation, cleaning processes and validation, controlling raw materials, documentation practices, personnel training, and quality control testing.

As the global veterinary pharmaceutical industry continues to evolve, adherence to these guidelines becomes imperative for safeguarding animal health and fostering public trust in veterinary medications. The implementation of harmonized guidelines internationally should provide greater clarity for manufacturers, especially manufacturers with global operations, thereby decreasing regulatory uncertainty and creating further opportunity for international recognition. While some manufacturers will be used to applying ICH Q7 principles to the manufacture of animal drug API, for others, especially internationally, compliance may require significant investment and preparation. In all cases, manufacturers should be planning ahead for the official raising of the bar for animal drug API GMP activities, and subsequent inspection readiness.

This draft guidance is published in the federal registrar and open to public comment until March 25, 2024.  Once the consultation has concluded internationally, the finalized guidelines are expected to be adopted in the United States, European Union, Japan, and other participating countries such as the UK.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.