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Oecd & Ich

The document outlines the regulatory guidelines for conducting toxicity studies, emphasizing the role of the International Council for Harmonisation (ICH) in harmonizing drug development standards globally. It details ICH's mission, key aspects such as global harmonization, and the stepwise process for guideline development and adoption. Additionally, it lists the members and observers involved in ICH, highlighting its importance in advancing public health and facilitating access to safe and effective medicines.

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SANJIV STAR PANDA
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1K views101 pages

Oecd & Ich

The document outlines the regulatory guidelines for conducting toxicity studies, emphasizing the role of the International Council for Harmonisation (ICH) in harmonizing drug development standards globally. It details ICH's mission, key aspects such as global harmonization, and the stepwise process for guideline development and adoption. Additionally, it lists the members and observers involved in ICH, highlighting its importance in advancing public health and facilitating access to safe and effective medicines.

Uploaded by

SANJIV STAR PANDA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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Regulatory guidelines for conducting

toxicity studies (OECD, ICH, EPA,


Schedule Y)
ICH
• The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is
unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects
of drug registration.
• It is a global organization representatives to harmonize guidelines
and standards for drug development, registration, and lifecycle
management.
• Key aspects of ICH:

• 1. Global harmonization: ICH aims to harmonize regulatory


requirements across regions (US, EU, Japan, and others).
• 2. Guidelines and standards: ICH develops and publishes guidelines
and standards for: -
• Quality (Q): Pharmaceutical quality, Good Manufacturing Practice
(GMP), etc.
• Safety (S): Toxicology, pharmacology, and biopharmaceutics.

• Efficacy (E): Clinical trials, statistics, and clinical evaluation.

• 3. Expert Working Groups: ICH has expert working groups


comprising regulatory agency and industry representatives to develop
• 4. Stepwise process: ICH guidelines go through a stepwise process:
• Step 1 (concept paper),
• Step 2 (draft guideline),
• Step 3 (final guideline), and
• Step 4 (implementation).
• Step 5. (Regulatory adoption): ICH guidelines are adopted by
regulatory agencies worldwide, facilitating global drug development
and registration.
• ICH's work enables:
• 1. Streamlined drug development 2. Increased efficiency 3.
Improved quality and safety 4. Global access to medicines
• By harmonizing regulatory requirements, ICH plays a crucial role in
advancing public health and facilitating the development of new
treatments.
Since its inception in 1990, ICH has gradually evolved, to respond to
the increasingly global face of drug development.
 ICH's mission is to achieve greater harmonisation worldwide to
ensure that safe, effective, and high quality medicines are developed and
registered in the most resource-efficient manner.
Since its announcement of organizational changes in June 2015, ICH
has grown as an organization and now includes 16 Members and 32
Observers (June 2024, 23 members and 35 observers)
• MEMBERS

• Founding Regulatory Members

• EC, Europe
• FDA, United States
• MHLW/PMDA, Japan
• Founding Industry Members

• EFPIA

• JPMA

• PhRMA

• Standing Regulatory Members

• Health Canada, Canada


• Regulatory Members

• ANVISA, Brazil

• HSA, Singapore

• MFDS, Republic of Korea

• NMPA, China

• SFDA, Saudi Arabia

• TFDA, Chinese Taipei

• TITCK, Turkey

• Industry Members

• BIO

• Global Self-Care Federation


• OBSERVERS

• Standing Observers

• IFPMA

• WHO

• Legislative or Administrative Authorities

• AEC, Azerbaijan

• ANMAT, Argentina

• CDSCO, India

• CECMED, Cuba

• COFEPRIS, Mexico

• CPED, Israel

• INVIMA, Colombia
• MHRA, UK
• MMDA, Moldova
• MOPH, Lebanon
• National Center, Kazakhstan
• NPRA, Malaysia
• NRA, Iran
• Roszdravnadzor, Russia
• SAHPRA, South Africa
• SCDMTE, Armenia
• TGA, Australia
• Regional Harmonisation Initiatives (RHIs)
• APEC
• ASEAN
• EAC
• GHC
• PANDRH
• SADC
• International Pharmaceutical Industry Organisation
• APIC
• International Organisation regulated or affected by ICH
Guideline(s)
• Bill & Melinda Gates Foundation
• CIOMS
• EDQM
• IPEC
• PIC/S

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