The International Council for Harmonisation (ICH) has introduced two new guidelines, with one (M9) providing recommendations to support the bio-pharmaceutics classification of medicinal products, while the other (M10) is applicable to the validation of bio-analytical methods and study sample analyses in nonclinical and clinical studies.
Both of the new strategies for the guidelines are part of efforts to harmonize regional differences in guidance documents and were finalized by ICH on 7 October. The release of the guidelines’ concept papers and business plans on 20th October adhere to the international expansion of the council last summer.
M9: Biopharmaceutics Classification System-based Biowaivers
This proposed guideline related to Biopharmaceutics Classification System (BCS) based bio-waivers is intended to help minimize the number and kind of bio-equivalence studies that have to be carried out, based on the region/regional guidance.
Currently, pharmaceutical companies have to follow certain approaches, particularly as the US, EU, Japan, Canada and WHO all offer different but at times overlapping guidance on bio-equivalence and bio-waivers.
“Biopharmaceutics Classification System (BCS)-based bio waivers may be applicable to BCS Class I and III drugs, however, BCS-based bio-waivers for these 2 classes are not recognized worldwide” ICH says. “Further, even the classification by itself may vary. This indicates that pharmaceutical companies have to follow different approaches in different regions.”
ICH states that the main issues to be resolved can be categorized into supportive data for the classification of the medicinal products into one of the 4 categories of BCS, and supportive data for the waiver by itself.
The recommendations in the ICH guideline will address:
- Supportive data for classification, which includes solubility and permeability
- Supportive data for a waiver, which could include establishing cut-off values of dissolution standards based on whether the drug is regarded a BCS Class I or a BCS Class III drug
ICH states that it expects to reach the second step of its process of adopting the guideline in the 1st half of 2018, while adoption of the Step 4 document is likely to occur in the 2nd quarter of 2019.
M10: Bioanalytical Method Validation
The other guideline will provide recommendations on the scientific regulatory specifications for bioanalysis conducted during the development of drugs and biologics.
ICH defines bio analysis as 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.
The EU, US and Japan each have different regulatory guidelines or draft guidance for bio-analytical method validation (BMV), which leads to obstacles for the mutual use of bio analytical data across regions.
The main technical and scientific issues in BMV can be categorized, according to ICH, as method validation, study sample analysis and other issues. The recommendations provided in the guideline will address the issues by considering the characteristics of the analytical procedures used in bio analysis, e.g., chromatographic assay and ligand binding assay.
ICH expects the adoption of the Step 2 document in the 2nd quarter of 2018 and the adoption of the Step 4 document a year later.