[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)] [Notices] [Pages 25634-25635] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-12157] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 96D-0028] International Conference on Harmonisation; Guideline on Stability Testing for New Dosage Forms; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing a guideline entitled ``Stability Testing for New Dosage Forms.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline addresses the generation of stability information for new dosage forms for submission to FDA by the owner of the original application. The guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.'' DATES: Effective June 9, 1997. Written comments may be submitted at any time. ADDRESSES: Submit written comments on the guideline to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Copies of the guideline are available from the Drug Information Branch (HFD-210), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Regarding the guideline: Guiragos K. Poochikian, Center for Drug Evaluation and Research (HFD-570), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1050. Regarding ICH: Janet J. Showalter, Office of Health Affairs (HFY- 20), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0864. SUPPLEMENTARY INFORMATION: 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 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, the Canadian Health Protection Branch, and the European Free Trade Area. In the Federal Register of March 6, 1996 (61 FR 9060), FDA published a draft tripartite guideline entitled ``Stability Testing for New Dosage Forms.'' The notice gave interested persons an opportunity to submit comments by June 4, 1996. After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies at the ICH meeting held on November 5, 1996. In the Federal Register of September 22, 1994 (59 FR 48754), FDA published a guideline entitled ``Stability Testing of New Drug Substances and Products.'' The guideline addresses the generation of stability information for submission to FDA in new drug applications for new molecular entities and associated drug products. For biotechnological/biological products, see ``Quality of Biotechnological/Biological Products: Stability Testing of Biotechnological/Biological Products'' (60 FR 43501, August 21, 1995). This guideline is an annex to that guideline and addresses the generation of stability information for new dosage forms for submission to FDA by the owner of the original application, after the original submission for new drug substances and products. This guideline represents the agency's current thinking on stability testing for new dosage forms. 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 statute, regulations, or both. As with all of FDA's guidelines, the public is encouraged to submit written comments with new data or other new information pertinent to this guideline. The comments in the docket will be periodically reviewed and, where appropriate, the guideline will be amended. The public will be notified of any such amendments through a notice in the Federal Register. Interested persons may, at any time, submit to the Dockets Management Branch (address above) written comments on the guideline. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guideline and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. An electronic version of this guideline is available on the Internet using the World Wide Web (WWW) (http://www.fda.gov/cder/guidance.htm). The text of the guideline follows: [[Page 25635]] Stability Testing for New Dosage Forms 1. General This document is an annex to the ICH Harmonized Tripartite Guideline on Stability Testing of New Drug Substances and Products and addresses the recommendations on what should be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new drug substances and products. 2. New Dosage Forms A new dosage form is defined as a drug product which is a different pharmaceutical product type, but contains the same active substance as included in the existing drug product approved by the pertinent regulatory authority. Such pharmaceutical product types include products of different administration route (e.g., oral to parenteral), new specific functionality/delivery systems (e.g., immediate release tablet to modified release tablet) and different dosage forms of the same administration route (e.g., capsule to tablet, solution to suspension). Stability protocols for new dosage forms should follow the guidance in the parent stability guideline in principle. However, a reduced stability database at submission time (e.g., 6 months accelerated and 6 months long-term data from ongoing studies) may be acceptable in certain justified cases. Dated: May 2, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-12157 Filed 5-8-97; 8:45 am] BILLING CODE 4160-01-F