ICH Proposes Two New Guidelines

The International Council on Harmonization (ICH) announced two new guidelines, with a (M9) to support the recommendations provided Biopharmaceutical Classification of drugs, while the other (M10) is applied to the validation of methods of bioanalysis and study no analysis sample preclinical and clinical studies.

The two new plans guidelines are part of efforts to harmonize regional differences in policy documents and were finalized by the ICH October 7. The publication of the guidelines document design and business plans on Thursday to continue the international expansion of the board last summer.

Biowaivers based on the Biopharmaceutics Classification system: M9

This proposed classification system that analyzes biopharmaceutical guide computer (BCS) based biowaivers is designed to help reduce the number and types of bioequivalence studies to be carried out, according to the targeted area / regional.

Currently, pharmaceutical companies must follow different approaches, particularly the United States, European Union, Japan, Canada and the World Health Organization at all times offer different advice, but overlapping biowaivers bioequivalence.

"Biopharmaceutics Classification System (BCS) biowaivers based computer may be applicable to BCS Class I and III drugs BCS but biowaivers basis for these two are not recognized worldwide classes," says ICH. "Also even the classification itself may be different. This means that pharmaceutical companies have different approaches in different regions."

ICH said that the main problems can be divided into information to support classification of drugs in one of the four BCS classes, and supporting information for the resignation itself.

The recommendations of the ICH guideline addressed:

• Supporting data for classification, treats, including solubility and permeability
• The data support a waiver, which could involve establishing criteria limits for dissolution of the drug is considered BCS BCS class I or III drugs

ICH said it expects to reach Phase 2 of the approval process of the Directive in the first half of 2018 STI, while approving the document Step 4 is likely to occur in the second quarter 2019

M10: Bioanalytical Method Validation

The new directive will provide recommendations on scientific regulatory requirements for the development of bioassays conducted during and biologics.

ICH bioassay defined as the quantification of drugs and metabolites in biological matrices His such as plasma, serum, blood, urine or other body fluids, which are performed in clinical and non-clinical studies.

EU, US and Japan have different regulatory guidelines or draft guidelines for validation of bioanalytical methods (BMV), which creates obstacles to the mutual use of data from bioassays in all regions.

The main technical and scientific issues can be classified BMV According ICH as method validation, analysis of the study sample and other issues. The recommendations outlined in the guidelines address issues taking into account the characteristics of the analytical methods used in bioassays, for example, the test and the chromatographic ligand binding.

ICH expect the adoption of the document Step 2 in the second quarter of 2018 and the adoption of the document in step four years later.