The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “S6 Addendum to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals” (S6 addendum). The S6 addendum was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The S6 addendum is intended to incorporate new knowledge and experience gained since the implementation of the ICH guidance entitled “S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals” (ICH S6) and to clarify and provide greater detail to enable the development of safe and effective biopharmaceuticals.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Anne M. Pilaro, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 2324, Silver Spring, MD 20993-0002, 301-796-2320; or Mercedes A. Serabian, Center for Biologics Evaluation and Research (HFM-760), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-4119. Regarding the ICH: Michelle Limoli, Office of International Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm 3506, Silver Spring, MD 20993, 301-796-4600.
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 December 17, 2009 (74 FR 66980), FDA published a notice announcing the availability of a draft guidance entitled “Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (S6)(R1).” The notice gave interested persons an opportunity to submit comments by February 1, 2010.
After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in June 2011.
The S6 addendum provides recommendations on nonclinical studies to support the safety of clinical trials and marketing applications for biotechnology-derived pharmaceuticals. Biotechnology-derived pharmaceuticals include protein therapeutic, diagnostic, and prophylactic products derived from cell-culture systems such as bacteria, yeast, and eukaryotic cells, including organisms produced by recombinant DNA technology. The S6 addendum incorporates new knowledge and experience gained since the implementation of the ICH S6 guidance in 1997 and provides clarification of and greater detail to the nonclinical recommendations in ICH S6 to enable the development of safe and effective biopharmaceuticals. The S6 addendum is intended to be used in conjunction with the original ICH S6 guidance. In general, the S6 addendum is complementary to ICH S6, and where the S6 addendum differs from ICH S6, the guidance in the S6 addendum prevails. In addition, the S6 addendum harmonizes approaches given in both ICH S6 and the ICH guidance “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals”
This 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.
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments 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.
III. Electronic Access
Persons with access to the Internet may obtain the document at http://www.regulations.gov,
Dated: May 14, 2012.
Assistant Commissioner for Policy.
[FR Doc. 2012-12039 Filed 5-17-12; 8:45 am]
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