What should be discussed in submission documents if the Scientific Advice from the CHMP is not followed?

When the Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) is not followed in submission documents, it is crucial to articulate the rationale for not adhering to that advice. This is important because the CHMP's guidance is based on extensive knowledge and expertise regarding regulatory requirements, scientific principles, and safety considerations.

Providing a clear rationale demonstrates due diligence and thoughtfulness in the development process. It indicates that the sponsor has carefully considered the advice given and has chosen a different approach based on sound reasoning. This rationale should detail the specific reasons for departing from the recommendations, such as new scientific data, differing clinical evidence, or alternative methodologies that may better suit the particular circumstances of the product being developed.

The rationale serves to assure regulators that the decision to deviate from the established guidance was made with careful consideration and is supported by credible evidence, underscoring the applicant's commitment to scientific integrity and patient safety. This type of information is essential for regulatory authorities to understand the context and basis for the decisions made during the development process.