The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan on June 2-7, 2012.

In June 2012, the ICH E3 Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing Content and Structure, Appendices and Terminology questions.

The MedDRA Management Board met in Fukuoka, Japan on 2-3 June 2012.

In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan proposing to develop new guidance on rodent carcinogenicity testing.

The ICH Q11 Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) reached Step 4 of the ICH Process on 1 May 2012 and now enters the Implementation phase (Step 5).

The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents to provide best practice approaches for data entry (coding) and data retrieval/analysis for MedDRA version release 15.0. The revised documents are available for download on the ICH website, under the MedDRA Point to Consider page.

Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP (July 2025) [Track version]

In March 2012, the ICH M3(R2) Implementation Working Group finalised under Step 4 of the ICH Process an additional set of Questions and Answers addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity and Juvenile Animal Studies.

The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 2 of the ICH Process in February 2012 and now enters the consultation period (Step 3).

Lenograstim End of procedure: 28/11/2011 Date of publication: 29/02/2012