The ICH, ICMRA, and PIC/S are three important international organizations in the pharmaceutical regulatory space that folks should pay attention to and understand how they shape our profession’s future.

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

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global initiative that brings together regulatory authorities and the pharmaceutical industry to discuss and establish common guidelines and standards for developing, registering, and post-approval pharmaceutical products.

History and Evolution

• Establishment: ICH was established in 1990 by the regulatory authorities and pharmaceutical industry associations from Europe, Japan, and the United States. The goal was to harmonize the regulatory requirements for pharmaceutical product registration across these regions.
• Reformation: In 2015, ICH was reformed and became a legal entity under Swiss law, transforming from the International Conference on Harmonisation to the International Council for Harmonisation. This change aimed to create a more robust and transparent governance structure and to expand its global reach.

Objectives and Goals

• Harmonization: The primary goal of ICH is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
• Efficiency: By harmonizing technical requirements, ICH aims to improve the efficiency of the drug development and registration process, reduce duplication of clinical trials, and minimize the use of animal testing without compromising safety and effectiveness.

Structure and Governance

• ICH Assembly: This is the overarching governing body, which includes all members and observers. It adopts decisions on guidelines, membership, work plans, and budgets.
• ICH Management Committee: This committee oversees the operational aspects, including administrative and financial matters and working group activities.
• MedDRA Management Committee: This committee manages the Medical Dictionary for Regulatory Activities (MedDRA), standardizing medical terminology for adverse event reporting and clinical trial data.
• ICH Secretariat: Handles the day-to-day management and coordination of ICH activities.

Guidelines and Categories

ICH guidelines are categorized into four main areas:

• Quality: Covers topics such as stability testing, analytical validation, and good manufacturing practices (GMP).
• Safety: Includes guidelines on genotoxicity, reproductive toxicity, and other safety evaluations.
• Efficacy: Focuses on the design, conduct, safety, and reporting of clinical trials, including novel drug classes and pharmacogenetics.
• Multidisciplinary: Encompasses cross-cutting topics like the Common Technical Document (CTD) and electronic standards for regulatory information transfer.

Global Impact and Implementation

• Membership: ICH includes regulatory authorities and industry associations from around the world. It currently has 20 members and 36 observers.
• Implementation: Regulatory members are committed to adopting and implementing ICH guidelines within their jurisdictions, ensuring consistent regulatory standards globally.

Key Activities

• Guideline Development: ICH develops harmonized guidelines through a consensus-based process involving regulatory and industry experts.
• Training and Support: Provide training materials and support to facilitate the consistent implementation of guidelines across different regions.

The ICH plays a crucial role in the global pharmaceutical regulatory landscape by promoting harmonized standards, improving the efficiency of drug development, and ensuring the safety and efficacy of medicines worldwide.

International Coalition of Medicines Regulatory Authorities (ICMRA)

The International Coalition of Medicines Regulatory Authorities (ICMRA) is a voluntary, executive-level, strategic coordinating, advocacy, and leadership entity. It brings together heads of national and regional medicines regulatory authorities worldwide to address global and emerging human medicine regulatory and safety challenges.

Objectives and Goals

• Global Coordination: ICMRA provides a global architecture to support enhanced communication, information sharing, crisis response, and addressing regulatory science issues.
• Strategic Direction: It offers direction for areas and activities common to many regulatory authorities’ missions and identifies areas for potential synergies.
• Leveraging Resources: ICMRA leverages existing initiatives, enablers, and resources to maximize the global regulatory impact wherever possible.

Membership

• Voluntary Participation: Membership is voluntary and open to all medicines regulatory authorities. It includes prominent entities such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and many others worldwide.
• Global Representation: The coalition includes regulatory authorities from various regions, with the World Health Organization (WHO) participating as an observer.

Key Activities and Projects

• Antimicrobial Resistance (AMR): Developing a coordinated global approach to tackle AMR.
• COVID-19 Response: During the COVID-19 pandemic, ICMRA has been pivotal in expediting and streamlining the development, authorization, and availability of COVID-19 treatments and vaccines worldwide.
• Innovation and Pharmacovigilance: Ongoing investigations and case studies relating to emerging regulatory challenges and working on real-world evidence, adverse event reporting, and vaccine confidence.
• Supply Chain Integrity: Ensuring the integrity of the global supply chain for medicines.

Strategic Importance

• Enhanced Collaboration: ICMRA fosters international collaboration among medicine regulatory authorities to ensure the safety, quality, and efficacy of medicinal products globally.
• Regulatory Agility: The coalition promotes regulatory agility and rapid response to global health emergencies, ensuring patients have timely access to safe and effective medical products.

The ICMRA plays a crucial role in the global regulatory landscape by enhancing communication and cooperation among medicines regulatory authorities, addressing shared challenges, and promoting the safety and efficacy of medicinal products worldwide.

Pharmaceutical Inspection Co-operation Scheme.

PIC/S stands for the Pharmaceutical Inspection Co-operation Scheme, a non-binding, informal co-operative arrangement between regulatory authorities in Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. Its main purpose is to lead the international development, implementation, and maintenance of harmonized GMP standards and quality systems of inspectorates in the pharmaceutical field.

History: PIC/S was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970. It was created to overcome legal limitations that prevented new countries from joining the original PIC due to incompatibilities with European law.

Membership: PIC/S is open to any regulatory authority with a comparable GMP inspection system. As of 2023, it comprises 56 participating authorities worldwide, including Europe, Africa, America, Asia, and Australasia.

Structure: PIC/S operates as an association under Swiss law, registered in Geneva, Switzerland. It has a committee, an executive bureau, and various working groups.

Relationship with Other Organizations: PIC/S works closely with other international bodies, including the European Medicines Agency (EMA), to promote GMP harmonization and share resources.

Objectives

• Harmonizing inspection procedures worldwide
• Providing training opportunities for inspectors
• Developing common standards in GMP
• Facilitating cooperation between competent authorities and international organizations

Activities

• Developing and promoting harmonized GMP standards and guidance documents
• Training competent authorities, particularly inspectors
• Assessing and reassessing inspectorates
• Facilitating networking among regulatory authorities

Benefits

• Ensures high standards among members
• Provides training and networking opportunities
• May facilitate pharmaceutical exports indirectly
• Increases confidence in medicines manufactured in member countries

PIC/S plays a crucial role in global pharmaceutical regulation by promoting harmonized standards, facilitating cooperation between regulatory authorities, and working towards ensuring the quality and safety of medicinal products worldwide.

The Three in Overview

Aspect	ICH	ICMRA	PIC/S
Full Name	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use	International Coalition of Medicines Regulatory Authorities	Pharmaceutical Inspection Co-operation Scheme
Established	1990 (reformed in 2015)	2013	1995
Primary Focus	Harmonization of technical requirements for drug development and registration	Strategic coordination and leadership in global human medicine regulation	Harmonization of Good Manufacturing Practice (GMP) standards and inspections
Main Objectives	Develop harmonized guidelines for drug development, registration, and post-approval	Enhance communication, information sharing, and crisis response among regulators	Develop common GMP standards and train inspectors
Membership	20 members, 36 observers (regulatory authorities and industry associations)	Heads of medicines regulatory authorities worldwide	Guideline development, training, and implementation support
Scope	Global, with emphasis on technical aspects of drug development	Global, focusing on high-level strategic issues	Global, concentrating on GMP and quality systems
Key Activities	Guideline development, training, implementation support	Strategic direction, crisis response, addressing emerging challenges	Inspector training, assessment of inspectorates, developing GMP guidance
Legal Status	Legal entity under Swiss law	Voluntary coalition	Non-binding, informal co-operative arrangement
Industry Involvement	Direct involvement of pharmaceutical industry associations	Limited direct industry involvement	No direct industry involvement
Main Output	Harmonized guidelines (Quality, Safety, Efficacy, Multidisciplinary)	Strategic initiatives, position papers, statements	GMP guidelines, inspection reports, training programs

This table highlights the distinct roles and focuses of these three important international pharmaceutical regulatory organizations. While they all contribute to global harmonization and cooperation in pharmaceutical regulation, each has a unique emphasis:

• ICH primarily develops technical guidelines for drug development and registration.
• ICMRA focuses on high-level strategic coordination among regulatory authorities.
• PIC/S concentrates on harmonizing GMP standards and inspection practices.

Their complementary roles contribute to a more cohesive global regulatory environment for pharmaceuticals.

How to Monitor

Organization	What to Monitor	How to Monitor	Frequency
ICMRA	– COVID-19 updates and guidance – Statements on regulatory issues – Reports on emerging topics (e.g., AI, RWE) – Strategic meetings and workshops	– Check ICMRA website regularly – Subscribe to ICMRA newsletter – Follow ICMRA on social media – Attend public workshops when possible	Monthly
ICH	– New and updated guidelines – Ongoing harmonization efforts – Implementation status of guidelines – Training materials and events	– Monitor ICH website for updates – Subscribe to ICH news alerts – Participate in public consultations – Attend ICH training programs	Bi-weekly
PIC/S	– GMP guide updates – New guidance documents – Training events and seminars – Inspection trends and focus areas	– Check PIC/S website regularly – Subscribe to PIC/S newsletter – Review annual reports – Participate in PIC/S seminars if eligible	Monthly

Key points for monitoring:

• Set up automated alerts or RSS feeds where available
• Create a calendar reminder for regular check-ins on each organization’s website
• Collaborate with regulatory affairs colleagues to share insights and updates
• Implement a system to disseminate relevant information within your organization
• Consider joining industry associations that actively engage with these organizations

Key Links

• https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmra
• https://icmra.info/drupal/sites/default/files/2022-10/icmra_fact_sheet.pdf
• https://www.ich.org
• https://picscheme.org/en/about-introduction