Guidelines on procedures and data requirements for changes to approved biotherapeutic products, Annex 3, TRS No 1011

Overview

Biotherapeutic products are an increasingly important component of global health care. Several WHO guidelines on the evaluation of biotherapeutic products have been produced that provide a set of principles on the regulatory evaluation of such products. During international consultations on the development of these guidelines, and their subsequent implementation, it became clear that there was a need for WHO guidance on making post-approval changes to biotherapeutic products in order to help address the complexity and other challenges associated with the global life-cycle management of such products. In May 2014, the Sixty-seventh World Health Assembly adopted two relevant resolutions: one on promoting access to biotherapeutic products and ensuring their quality, safety and efficacy and the other on regulatory systems strengthening. In support of these resolutions, WHO was requested to provide guidance on how to deal with increasingly complex biotherapeutic products, including similar biotherapeutic products (SBPs). In addition, the 16th International Conference of Drug Regulatory Authorities recommended that WHO assist Member States in ensuring regulatory oversight throughout the lifecycle of biotherapeutic products.

These WHO Guidelines provide guidance for NRAs and marketing authorization holders on the regulation of changes to the original marketing authorization dossier or product licence for an approved biotherapeutic product in terms of: (a) the procedures and criteria for the appropriate categorization and reporting of changes; and (b) the data required to enable NRAs to evaluate the potential impact of the change on the quality, safety and efficacy of the product. Additionally, the purpose of these WHO Guidelines is to assist NRAs in establishing regulatory procedures for post-approval changes to such products.

Full version of the WHO Technical Report Series N° 1011