ICH Adopts Pharmacopeial Text Annexes and Prepares for Global Quality Implementation

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts. Three annexes, 7 Dissolution, 9 Tablet Friability, and 10 Polyacrylamide Gel Electrophoresis, all reached Step 4 (adoption) of the harmonization process, according to an ICH press release. The annexes had just reached Step 3 (regulatory consultation and discussion) of the harmonization process during the past year, demonstrating international support for uniting the way pharmacopeial standards are used. Although ICH guidelines are not mandatory, the next step for these three annexes is to be reviewed and published by the regulatory bodies in the US, Europe, and Japan. Annex 11 Capillary Electrophoresis and Annex 12 Analytical Sieving to the Q4B guideline reached Step 2 (consensus by the six ICH parties) during the meeting.

Also of interest to the pharmaceutical manufacturers, ICH's Quality Implementation Working Group, which is focusing on the quality trio (Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), set a schedule for training workshops in each of the three ICH regions. This training will consist of case studies representing the four phases of the life cycle of a pharmaceutical product, according the ICH release. The workshops will be held in Brussels in June 2010, in Washington, DC, in October 2010, and in Tokyo in November 2010.

Other highlights of the meeting: ICH S9 Nonclinical Evaluation of Anticancer Pharmaceuticals reached Step 4 of the harmonization process. ICH S6 Revision of Preclinical Safety Evaluation of Biotechnology-derived Pharmaceuticals reached Step 2. In addition, ICH safety experts held a day-long brainstorming session to discuss how to fill current gaps in safety guidelines.

The next ICH Steering Committee will be held in Europe in June 2010. The group meets twice every year.