Europe – Qualification of novel methodologies for drug development: guidance to applicants

The EMA qualification process is a new, voluntary, scientific pathway leading to either a CHMP Qualification opinion or a qualification advice on innovative methods or drug development tools:

• CHMP qualification opinion on the acceptability of a specific use of the proposed method (e.g. use of a novel methodology or an imaging method) in a research and development (R&D) context (non-clinical or clinical studies), based on the assessment of submitted data;

• CHMP qualification advice on future protocols and methods for further method
development towards qualification, based on the evaluation of the scientific rationale and on preliminary data submitted.

As the scientific knowledge and the intended use of a new method may change in line with the generation of additional data the EMA qualification process may encompass an ongoing interaction between the CHMP and the applicant. Prior to final adoption of a qualification opinion, the CHMP evaluation, being open to public consultation of the scientific community will ensure that CHMP shares information and is open to enlarged scientific scrutiny and discussion. The impact of the qualification on regulatory technical standard also requires that the international dimension of the scientific evaluations is accommodated for within the available confidentiality arrangements…