SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area.

In the Federal Register of July 13, 2007 (72 FR 38604), FDA published a notice announcing the availability of a draft guidance entitled “Q10 Pharmaceutical Quality System.” The notice gave interested persons an opportunity to submit comments by October 11, 2007.

After consideration of the comments received and revisions to the guidance, ( printed page 15991) a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in June 2008.

The ICH Q10 guidance provides recommendations for a comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable GMP regulations and complements ICH “Q8 Pharmaceutical Development” and “Q9 Quality Risk Management.” The guidance describes a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of the guidance applicable to manufacturing sites is currently specified by regional GMP requirements. The guidance is not intended to create any new expectations beyond current regulatory requirements.

The ICH Q10 guidance demonstrates industry and regulatory authorities' support of an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of the provisions of the guidance throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.

In 2006, FDA published a guidance for industry entitled “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations” (October 2, 2006, 71 FR 57980). The 2006 guidance describes the key elements of a robust quality systems model and shows how implementation of such a model is one way to comply with FDA's current good manufacturing practice (CGMP) regulations. The 2006 guidance shows the correlation of ICH Q10 quality system components to FDA's CGMP regulations.

The ICH Q10 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written comments on the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.