INTERNATIONAL CONFERENCE ON HARMONISATION (ICH)
What is ICH ?
ICH is a process by which the regulatory authorities of US, the EC, Japan and experts from the pharmaceutical industry and trade associations in the three regions have been brought together.The objective of the process is to discuss scientific and technical aspects of medicinal product registration.
ICH topics and Guidelines:
ICH guidelines are divided into topics covering Quality(Q), Safety(S) and Efficacy(E). A fourth topic covers Multidisciplinary(M) topics.
The Tripartite guideline which has been developed within the Expert working group (Quality) provides a general requirements for the stability testing. It primarily address the information required in application for registration of New Drugs and associated drug products.
Classification of Zones:
|Region||Zone I and II countries||Zone III and IV countries|
|America||Argentina, Bolivia, Chile, Canada, Mexico, Peru, Urugay, USA||Barbados, Belize, Brazil, Costa Rica, Dominican Republic, Ecuador,
El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch Antilles, Panama, Paraguay, Puerto Rico, Venezuela.
|Asia||Afghanistan, Armenia, Azerbaijan, china, Georgia, Iran, Israel, Japan, Kazakhstan, Kirghizia, Korea, Lebanon, Nepal, Syria, Tadzhikistan, Turkey, Turkmenia, Uzbekistan||Bahrain, Bangladesh, Hong Kong, India, Indonesia, Iraq (III), Jordan (III), Kampuchea, Qatar, Kuwait, Laos, Malaysia, Maldives Islands, Myanmar, Oman, Oman, Pakistan, Philippines, Saudi Arabia, Singapore, Shri Lanka, Taiwan, Thailand, United Arab Emirates, Vietnam, Yemen.|
|Africa||Egypt, Algeria,Tunisia, Libya, Morocco, Namibia, Rwanda, South Africa, Zambia, Zimbabwe.||Angola, Ethiopia, Benin, Botswana (III), Burkina Faso, Burundi, Djibouti, Ivory Coast, Gabon, Gambia, Ghana, Guinea, Cameroon, Kenya, Longo, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Nigeria, Senegal, Sierra Leone, Somalia, Sudan, Tanzania, Togo, Chad (III), Uganda, Zaire, Central African Republic.|
|Australia, New Zealand.||Fiji, Society Islands, Marshould Islands, New Caledonia, Papua-New Guinea, Samoa, Tonga.|
Quality Guidelines : (Stability)
Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision) :
Q1B: Photostability Testing of New Drug Substances and Products:
Q1C: Stability Testing for New Dosage Forms:
Q1D: Bracketing & Matrixing Designs for Stability Testing of Drug Substances & Drug Products:
Q1E: Evaluation of Stability Data:
Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV: