1. Pink Sheet
  2. >>Geography
  3. >>International

ICH Proposes Harmonized Bioequivalence Standards For Solid Oral Drugs

 
• By Vibha Sharma

The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.

Businesswoman in front of many different doors choosing one. Difficult decision, important choice concept, failure or success.
Existing national and international guidelines have different requirements for bioequivalence study design and data analysis • Source: Shutterstock

The International Council for Harmonisation has proposed standardized bioequivalence (BE) study requirements for immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules and granules/powders for oral suspension.

The draft ICH M13A guideline was keenly awaited by generic drug manufacturers, who need to undertake BE assessments for these oral dosage forms to establish therapeutic equivalence of the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from International

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

More from Geography

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.