The guidance is limited to applications intended for the Great Britain (England, Wales and Scotland) market only. From 1 January 2021, reference medicinal products (RMP) for new generic medicines or other abridged marketing authorisation applications will be required to comply with the relevant legislation. Generally, the CP should be sourced from Great Britain (England, Wales and Scotland)
This guidance applies to BE, PK and TE studies provided in support of applications made under any of the above legal bases. In case of complex products, it is recommended that we are consulted for specific advice. This guidance should always be read in conjunction with relevant scientific guidelines and legislative provisions in force in the UK.
It will be the applicant's responsibility to demonstrate that any CP authorised and sourced from outside Great Britain is representative of the RMP. The non-Great Britain CP used is required to be representative of the RMP, but it is not required to be identical to it.
The type of bridging data needed should always include data from analytical studies that compare all three (3) products. The excipients in the formulation of the RMP, when compared to the non-Great Britain CP, should be qualitatively the same. Any differences in excipients would need to be shown to have no effect on safety or efficacy.
In cases of products that exhibit a higher inherent batch-to-batch variability or that are complex, a larger number of batches might be required to establish representativeness. The precision and accuracy of the analytical methods and the inter-batch variability are critical to deciding if the formulations of the RMP and non-Great Britain CP are representative of each other.