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ICH Guidelines

The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories.

Q

"Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance.
Examples: Q1 Stability Testing, Q3 Impurity Testing

S

"Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies.
Examples: S1 Carcinogenicity Testing, S2 Genotoxicity Testing

E

"Efficacy" Topics, i.e., those relating to clinical studies in human subject.
Examples: E4 Dose Response Studies, Carcinogenicity Testing, E6 Good Clinical Practices. (Note Clinical Safety Data Management is also classified as an "Efficacy" topic - E2)

M

"Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories.

 

Notes on implementation in the three ICH Regions

 

EU

The ICH guidelines are submitted to the Committee for Human Medicinal Products (CHMP) for endorsement once they have reached Step 2 or Step 4 of the ICH Process. The CHMP, in consultation with the European Commission decides on the duration for consultation with interested parties (up to 6 months).

The European Agency for the Evaluation of Medicinal Products (EMEA) publishes and distrubutes the Step 2 guidelines for comments. At Step 4 the guidelines are endorsed by the CHMP and a timeframe for implementation is established (usually 6 months).

The guidelines are subsequently published by the European Commission in the Rules Governing Medicinal Products in the European Union (http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm). 

 Step 2 and Step 4 guidelines are available from the EMEA site on the Internet:
http://www.emea.europa.eu/htms/human/ich/background.htm

MHLW

When Step 2 or Step 4 has been reached, the ICH texts are translated into Japanese. Subsequently Pharmaceutical and Medical Safety Bureau (PMSB) Notification for the promulgation or consultation of guidelines written in Japanese is issued with a deadline for comments in the case of consultation drafts, or an implementation date for finalised guidelines. The notifications on guidelines in Japanese and also English attachments (ICH Texts) are available from PMSB or on the Internet by the Pharmaceutical and Medical Devices Agency (PMDA).
http://www.pmda.go.jp/ich/ich_index.html

FDA

When Step 2 or Step 4 has been reached, FDA publishes a notice with the full text of the guidance in the Federal Register. Notices for Step 2 guidances include a date for receipt of written comment; Step 4 guidances are available for use on the date they are published in the Federal Register. FDA guidances and guidelines are available on the Internet:
CDER: http://www.fda.gov/cder/guidance/index.htm
CBER: http://www.fda.gov/cber/guidelines.htm