Notice to stakeholders on implementing ICH M13B: Bioequivalence for immediate release solid oral dosage forms: Additional strengths biowaiver

November 4, 2026
Our file number: 26-106095 – 825

On this page

• Background
• Impact on current Health Canada guidance documents
• Additional strengths biowaiver requests for modified-release dosage forms
• Contact us

Background

The International Council for Harmonisation (ICH) adopted ICH M13B: Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver on August 4, 2026.  This guideline provides recommendations on obtaining waivers of bioequivalence (BE) studies (biowaivers) for additional strengths of a drug product that has demonstrated, for at least one strength:

• efficacy and safety or
• in vivo pharmacokinetic (PK) BE

The guideline applies during both development and post-approval phases of orally administered immediate-release (IR) solid dosage forms intended to deliver drugs to the systemic circulation, such as:

• tablets
• capsules
• granules or powders for oral suspension

Health Canada will implement ICH M13B on February 4, 2027. Additional strengths biowaiver requests for IR solid oral dosage forms included in submissions filed on or after this date must comply with ICH M13B and this notice.
Read ICH M13B in conjunction with other applicable Health Canada guidance documents.

Learn more:

• ICH M13B: Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver (PDF, 1.3 MB) (English only)

Impact on current Health Canada guidance documents

The ICH M13B guideline will supersede Bioequivalence of Proportional Formulations: Solid Oral Dosage Forms for information related to additional strengths biowaivers for IR dosage forms.  The rest of this guidance document will still apply.

Learn more:

• Bioequivalence of Proportional Formulations: Solid Oral Dosage Forms

Incoming updates

Implementing ICH M13B will cause changes to the Bioequivalence of Proportional Formulations: Solid Oral Dosage Forms guidance document.

Section of the proportionality guidance	Status after implementing ICH M13B
Introduction	Introduction remains applicable for MR dosage forms. However, ICH M13B supersedes the guidance for IR dosage forms.
Section 1.1	Superseded by ICH M13B. For the purpose of this guidance, “conventional-release dosage forms” are considered to be “immediate-release dosage forms”.
Section 1.2	Remains applicable
Section 2.1	Superseded by ICH M13B. The data requirements for an additional strengths biowaiver requests described in the ICH M13B guideline are applicable to IR dosage forms containing drugs described in Comparative Bioavailability Standards: Formulations Used for Systemic Effects (sections 2.1.1.2 to 2.1.1.10). Learn more: Comparative Bioavailability Standards: Formulations Used for Systemic Effects
Section 2.2	Remains applicable

Previous updates

In 2012, the references to these documents were replaced:

• Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects (1992)
• Report B of the Expert Advisory Committee on Bioavailability and Bioequivalence: Report on Bioavailability of Oral Dosage Formulations of Drugs Used For Systemic Effects: Modified Release Dosage Formulations (1992)

They were replaced by these guidance documents:

• Conduct and Analysis of Comparative Bioavailability Studies
• Comparative Bioavailability Standards: Formulations Used for Systemic Effects

References to this document were also replaced in 2012:

• Report C of the Expert Advisory Committee on Bioavailability and Bioequivalence: Report on Bioavailability of Oral Dosage Formulations, Not in Modified Release Form, of Drugs Used for Systemic Effects, Having Complicated or Variable Pharmacokinetics (1992) (referred to as Report C)

They were replaced by this guidance document:

• Comparative Bioavailability Standards: Formulations Used for Systemic Effects
  • Sections 2.1.1.2 to 2.1.1.7
  • Section 2.1.1.10

Some of Health Canada's bioequivalence guidance framework was later superseded by ICH M13A.
Learn more:

• Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms

Additional strengths biowaiver requests for modified-release dosage forms

ICH M13B only applies to IR dosage forms. Until further notice, Bioequivalence of Proportional Formulations: Solid Oral Dosage Forms continues to apply for additional strengths biowaiver requests involving modified-release (MR) dosage forms.
Revised bioequivalence standards for single-dose comparative bioavailability studies conducted with MR dosage forms are described in Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms.

Learn more:

• Bioequivalence of Proportional Formulations: Solid Oral Dosage Forms
• Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms

Contact us

Contact Health Canada’s ICH coordinator with:

• comments or questions
• requests for a French version of ICH M13B

Email: ich@hc-sc.gc.ca