Latest Regulatory Updates

The International Council for Harmonisation (ICH) has made the presentation for ICH Q13 Step 2, concerning genotoxic impurities in drug substances and products, available on its website to facilitate understanding of the guideline.

The ICH Q13 draft guideline on Mineral Impurities in Drug Substances and Products has advanced to Step 2 of the ICH process, signifying public consultation and feedback collection.

The International Council for Harmonisation (ICH) received the 2021 DIA Award for Outstanding Contribution to Health, recognizing its efforts in harmonizing regulatory requirements for pharmaceuticals.

This ICH Information Paper provides guidance on the implementation of ISO IDMP standards within ICH E2B(R3) messages, aiming to enhance data quality and interoperability for adverse event reporting.

The International Council for Harmonisation (ICH) has made the Step 2 presentation for guideline S12, relating to clinical evaluation of health products for specific patient populations, available on its website.

The ICH Assembly held a virtual meeting in June 2021, during which progress on various guideline revisions and new initiatives was discussed, including Q3A(R), P9, and M12.

The ICH S1B(R1) draft guideline, concerning the identification and characterization of genotoxic impurities in drug substances, has advanced to Step 2 within the ICH process, signaling a public consultation phase for stakeholder feedback.

SNOMED International and ICH have initiated a collaboration to enhance data exchange capabilities, aiming for greater interoperability and improved public health outcomes through standardized terminology.

The ICH E6(R3) Expert Working Group will host a public web conference on October 26, 2023, to discuss the upcoming addendum to the Integrated Guideline on Good Clinical Practice – Additional Considerations for Risk-Based Approaches.

The ICH Q3C(R8) guideline, which addresses impurities in new drug substances, has reached Step 4 of the ICH process, indicating it is nearing finalization and potential adoption by regulatory bodies worldwide.

ICH is seeking proposals from qualified auditors to support audits of MedDRA MSSO (Medical Dictionary for Drug Regulatory Activities Master System Server Operations) operations, ensuring ongoing compliance and maintenance of the dictionary's integrity.

The International Council for Harmonisation (ICH) has released draft principles for ICH E6 Good Clinical Practice (GCP), aiming to modernize and enhance the standards for designing, conducting, recording, and reporting clinical trials.

The International Council for Harmonisation (ICH) has advanced the eCTD v4.0 Q&A v1.4 document to Step 4 of the ICH process, indicating it is nearing completion and potential adoption as a standard.

The International Council for Harmonisation (ICH) is seeking public consultation on a reflection paper outlining considerations for incorporating Patient-Focused Drug Development (PFDD) principles into regulatory processes.

The ICH Assembly held a virtual meeting in November 2020, during which progress on various guideline revisions and new initiatives was discussed, including those related to quality risk management, data integrity, and control strategies for biotechnological/biological products.

The International Council for Harmonisation (ICH) has made the Step 2 presentation for ICH Q3D(R2), which addresses impurity thresholds in drug substances and products, available on its website.

The International Council for Harmonisation (ICH) has released a draft revised guideline, Q3D(R2), addressing genotoxic impurities in new drug substances and provides updated recommendations for risk assessment and control.

The International Council for Harmonisation (ICH) has released draft Questions and Answers (Q&As) related to the E14/S7B guideline on ethnic factors in clinical drug development, intended to provide further clarification and guidance to stakeholders.

The International Council for Harmonisation (ICH) has made an introductory training presentation on ICH S11, Development and Validation of Analytical Methods, available on its website to facilitate understanding and implementation of the guideline.

The International Council for Harmonisation (ICH) has released version 1.1 of the E2B(R3) User Guide, providing updated guidance on clinical trial data requirements for regulatory submissions.