ICH details milestones reached on guidelines after Athens meeting

Regulatory NewsRegulatory News | 02 June 2022 |  By 

The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for testing pharmaceuticals and extrapolating adult clinical trial data to the pediatric populations.
The ICH announcement follows its 21-25 May meeting in Athens, Greece which was held in a hybrid format. The meeting included seven working groups, as well as the ICH Management Committee, the MedDRA Management Committee and the ICH Assembly.
The Assembly noted that “significant milestones” were made by several working groups since the last ICH meeting.
One such milestone was the issuance of the revised ICH Q2(R2) as a Step 2 draft guideline in March 2022 on “Validation of Analytical Procedures” that provides guidance on the principles of analytical procedures validation, adding validation principles for near-infrared (NIR)-based analysis and Raman spectroscopy. (RELATED: ICH releases draft guidelines on analytical method development, Regulatory Focus 31 March 2022)
In addition, the ICH announced that its ICH Q14 guideline on “Analytical Procedure Development” reached Step 2 in March 2022. The guideline aims to harmonize analytical procedures development and make it easier for manufactures to switch analytical methods for testing medicines postapproval and is designed to complement the ICH Q2(R2) guideline.
Another development was the release of the ICH E11 draft guidelines on “Pediatric Extrapolation,” which reached Step 2 in April 2022. The guideline advances a harmonized approach for extrapolating drug development data from adult trials to the pediatric population. (RELATED: ICH drafts guideline on pediatric extrapolation in drug development, Regulatory Focus 6 April 2022)
Another sign of progress was the release of the Step 4 ICH E14/S7B updated Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” in February 2022. The document provides a harmonized framework for integrating nonclinical and clinical information for proarrhythmia risk assessments.
In addition, ICH reports that progress has been made in advancing the following guidelines:
ICH announced that ICH M7(R2) Q&As on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has reached Step 4. ICH said that the Q&As “will be published alongside the M7(R2) revised ICH Guideline and Addendum which are also expected to reach Step 4 shortly.”
Another accomplishment was the release of the ICH M8 guideline on the electronic common document (eCTD) v4.0 Q&As and v1.7 on the Specification Change Request Document and eCTD v4.0 Implementation Package v1.5 as Step 4 documents.
In addition, the ICH M10 Guideline on “Bioanalytical Method Validation and Study Sample Analysis” reached Step 4. The guideline provides recommendations for validating bioanalytical assays and outlines principles for improve the quality of bioanalytical data in the development and approval of chemical and biological drugs.
ICH also noted that its draft ICH M12 Guideline on “Drug Interactions Studies” reached Step 2 at the meeting. The guideline aims to harmonize an approach in designing and interpreting drug-drug interaction studies during product development.
New topic covering pregnant women in clinical trials
In other areas, the ICH Assembly endorsed the development of a new ICH efficacy guideline that addresses pregnant and breastfeeding individuals in clinical trials. ICH announced “the COVID-19 pandemic has illustrated the importance” of developing a “well-defined harmonized international guideline which will benefit this underserved population, regulators, healthcare providers and the pharmaceutical industry globally.”
The Assembly was also briefed on new training materials being developed for ICH guidelines. These materials will be created for ICH E6(R3), E8(R1), E17, Q3, Q5 and the ICH Q8 to Q12 series of guidelines.
New MedDRA translations
ICH also announced that the Medical Dictionary for Regulatory Activities (MedDRA) has been updated to include Swedish and Latvian MedDRA translations in Version 25.0 and is now available in 16 languages. This supplements ongoing work to translate MedDRA into Greek, Arabic, Polish, Maltese, Estonian, Icelandic, and Norwegian.
Close to 7,500 organizations in 130 countries now subscribe to MedDRA. In addition, collaborative work is being undertaken to map MedDRA with other terminologies. The second production of the SNOMED CT- MedDRA mappings was released in May 2022. In addition, a new Standardized MedDRA Query (SMQ) for noninfectious myocarditis/pericarditis has been included in the MedDRA Version 25.0 March release.
UK MHRA newest member
ICH announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined as a new member. Also, Algeria’s National Agency of Pharmaceutical Products (ANPP) has joined as a new observer, bringing the number of ICH members to 20 members and 35 observers.
The next ICH Assembly meeting will be held 15-16 November 2022 in Incheon, Republic of Korea.


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Tags: E11, ICH, M10, M7, MedDRA, Q14, Q2(R2)

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