Regulatory Focus™ > News Articles > ICH Proposes Two New Guidelines

ICH Proposes Two New Guidelines

Posted 21 October 2016 | By Zachary Brennan 

ICH Proposes Two New Guidelines

The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies.

Both of the new plans 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 Thursday follow the international expansion of the council last summer.

M9: Biopharmaceutics Classification System-based Biowaivers

This proposed guideline addressing Biopharmaceutics Classification System (BCS)-based biowaivers is intended to help minimize the number and type of bioequivalence studies that have to be carried out, depending on the region/regional guidance.

Currently, pharmaceutical companies have to follow different approaches, particularly as the US, EU, Japan, Canada and World Health Organization all offer separate but at times overlapping guidance on bioequivalence and biowaivers.

“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,” ICH says. “In addition, even the classification itself may differ. This means that pharmaceutical companies have to follow different approaches in the different regions.”

ICH says the main issues to be resolved can be divided into supportive data for the classification of the medicinal products into one of the four classes of BCS, and supportive data for the waiver itself.

The recommendations in the ICH guideline will address:

  1. Supportive data for classification, including solubility and permeability
  2. Supportive data for a waiver, which could involve establishing cut-off values of dissolution criteria depending on whether the drug is considered a BCS Class I or a BCS Class III drug

ICH says it expects to reach Step 2 of its process of adopting the guideline in the first half of 2018, while adoption of the Step 4 document is likely to occur in the second quarter of 2019.

M10: Bioanalytical Method Validation

The other guideline will provide recommendations on the scientific regulatory requirements for bioanalysis conducted during the development of drugs and biologics.

ICH defines bioanalysis 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 bioanalytical method validation (BMV), which creates hurdles for the mutual use of bioanalytical 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 methods used in bioanalysis, e.g., chromatographic assay and ligand binding assay.

ICH expects the adoption of the Step 2 document in the second quarter of 2018 and the adoption of the Step 4 document a year later.

Final endorsed Concept Paper M9: Biopharmaceutics Classification System-based Biowaivers

Final endorsed Business Plan M9: Biopharmaceutics Classification System-based Biowaivers

Final endorsed Concept Paper M10: Bioanalytical Method Validation

Final endorsed Business Plan M10: Bioanalytical Method Validation


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