FDA Begins Consultation on Two ICH Guidelines

Posted 08 September 2016 | By Michael Mezher

FDA Begins Consultation on Two ICH Guidelines

The US Food and Drug Administration (FDA) has issued two new International Council for Harmonisation (ICH) guidelines for public consultation: one on multi-regional clinical trials (MRCTs) and one on microsampling in study animals.

Once ICH adopts a guideline, it then goes to ICH's five regulatory members in the US, EU, Canada, Japan and Switzerland for regional or national consultation before it can be implemented as an internationally harmonized document.

Multi-Regional Clinical Trials

In June, ICH adopted its ICH E17 General Principles for Planning and Design of Multi-Regional Clinical Trials, which is intended to help sponsors design multi-regional clinical trials while reducing unnecessary duplication.

"Globalisation of drug development has increased the use of [multi-regional clinical trials] MRCTs for regulatory submissions in ICH regions as well as in non-ICH regions. Currently, it may be challenging both operationally and scientifically to conduct a drug development programme globally, in part due to distinct and sometimes conflicting requirements from regulatory authorities," the guidance says.

According to the guidance, MRCTs are helpful for drugmakers looking to more quickly recruit trial participants from a more diverse population.

Furthermore, the guidance says that "MRCTs can facilitate simultaneous global drug development by reducing the number of clinical trials that need to be conducted separately in each region, thereby avoiding the ethical issue of unnecessary duplication of studies."

This, the guidance says, can lead to fewer delays in product approval across multiple regions, as the sponsor should be able to submit data from the MRCT to multiple regulators at the same time.

Figure 1. Clinical Drug Development Across Multiple Regions



The other draft guidance released is intended to provide clarification on the use of microsampling, which involves drawing tiny amounts of blood—less than 50 microliters (μl)—from animals for testing purposes.

Adopted by ICH in May, ICH S3A Guideline: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure Toxicity Studies, Questions and Answers, provides insights on when pharmaceuticals microsampling is appropriate, sampling methods and the effect they might have on toxicity data, as well as considerations for bioanalytical methods development and validation.

While ICH's primary S3A guideline was implemented in 1994, recent technological advances have allowed for increased use of microsampling in toxicokinetics.

By reducing the amount of blood drawn, ICH says microsampling can reduce pain and distress in study animals, and can even reduce the number of animals required in a toxicokinetics study.

E17 General Principles for Planning and Design of Multi-Regional Clinical Trials

ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies – Questions and Answers

Tags: data, Integrity

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