ICH Assembly

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly

The ICH Assembly is the overarching governing body of the ICH Association that makes decisions regarding the Articles of Association and its Rules of Procedures, admission of new Members, election of Elected MC representatives, annual work plan, adoption of ICH Guidelines, approval of budget, etc. It brings together all Members and Observers of the ICH Association.

The main roles of the ICH Assembly include:

• Adopting Decisions: The Assembly adopts decisions on matters such as the Articles of Association, admission of new Members and Observers, and the adoption of ICH Guidelines.
• Guideline Development: It oversees the development and implementation of harmonized guidelines and standards to improve the efficiency of new drug development and registration processes.
• Meeting Biannually: The Assembly meets twice a year to discuss and make decisions on various topics related to pharmaceutical harmonization.
• Preventing Duplication: One of the key benefits of the ICH Assembly’s work is preventing the duplication of clinical trials in humans and minimizing the use of animal testing without compromising safety and effectiveness.

The ICH Assembly contributes to the validation of NAMs through several key initiatives:

• Harmonization of Guidelines: The Assembly adopts harmonized guidelines that include the use of NAMs. These guidelines help streamline the regulatory assessment process for new drug applications and reduce the development times and resources required.
• Public Consultation: The ICH process includes public consultation on draft guidelines, allowing for input from various stakeholders, including those involved in the development and validation of NAMs.
• International Collaboration: By bringing together regulatory authorities and the pharmaceutical industry from around the world, the ICH Assembly facilitates international collaboration on the development and acceptance of NAMs.
• Topic Selection and Review: The Assembly reviews and selects new topics for harmonization, which can include NAMs. This ensures that the latest scientific advancements are considered and integrated into regulatory practices.