EMEA: Qualification of novel methodologies for drug development: Guidance to applicants

As the scientific knowledge and the intended use of a new method may change in line with the generation of additional data the EMEA 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.