ICH Guidances

The ICH process results in guidance documents that create consistency in the requirements for new drug approval. Guidance documents represent the Agency ’ s current thinking on a particular subject. These documents provide guidance on the processing, content, evaluation, and approval of applications. They also establish policies intended to achieve consistency in the Agency ’ s regulatory approach and establish inspection and enforcement procedures. Because guidances are not regulations or laws, they are not enforceable, eitherthrough administrative actions or through the courts. An alternative approach may be used if such an approach satisfi es the requirements of the applicable statutes, regulations, or both.

ICH guidances are developed through a fi ve - step process: (1) consensus building, (2) start of regulatory action, (3) regulatory consultation, (4) adoption of text, and (5) implementation.

When a guidance document reaches Step 2 or Step 4 in the ICH process, the FDA publishes a notice of
availability in the Federal Register . Guidances are posted on the Internet and placed in the Docket for viewing and public comment. Notices for Step 2 guidances include a date for receipt of written comment. Because Step 2 documents are drafts, they do not conform with the Agency ’ s Good Guidance Practices (GGP) policy. Step 4 guidances must be reformatted and edited to be consistent with the GGPs. This is because the 1997 U. S. Food, Drug and Cosmetic Act required the Agency to make GGPs the law.