On 7 October 2016 the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published two Final Endorsed Concept Papers (i.e., step 1 of the process).
M9: Biopharmaceutics Classification System-based Biowaivers
This proposed new multidisciplinary guideline will address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to
support the waiver of bioequivalence studies.
This will result in the harmonisation of current regional guidelines/guidance and support streamlined global drug development.
Biopharmaceutics Classification System (BCS)-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. Regulatory guidelines/draft guidance which includes the possibility of BCS-based biowaivers have been issued in, for instance, the EU, US, Canada and within the WHO. Also, Japanese guideline includes the possibility of biowaivers based on the extent of formulation change. However, it appears from these guidelines that BCS based biowaivers may not be recognized globally or that the requested supportive data for such applications differs. In addition, even the classification itself may differ. This means that pharmaceutical companies have to follow different approaches in the different regions.
M10: Bioanalytical Method Validation
The proposed new multidisciplinary guideline will apply to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. This guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs of both chemical and biological origins. This will result in the harmonisation of current regional guidelines/guidances and support streamlined global drug development.
Bioanalysis herein means the quantification of drugs and their metabolites in biological matrices such as plasma, serum, blood, urine or other body fluids, which are conducted in non-clinical and clinical studies. Reliable data derived through validated bioanalytical methods are key for the review of marketing authorisation application.
In the EU, US and Japan, regulatory guidelines or draft guidances for bioanalytical method validation (BMV) have been issued and recommendations on basic requirements are established for these nations/regions. However, several differences in method validation and study sample analysis exist among these guidelines/guidances and remain hurdles for the mutual use of bioanalytical data in global drug development. This means that sponsors, pursuing global approvals, are required to reconcile multiple guidelines/guidances in different countries and often requires unnecessary duplicative testing in order to meet the variable requirements.
The draft of M10 (step 2) was endorsed on Feb 26, 2019 for public consultation.
document date 2016-10-07 | last update 2022-10-19