This guideline was developed within the Expert Working Group (Quality) of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. This document has been endorsed by the ICH Steering Committee at Step 4
of the ICH process, November 29, 1995. At Step 4
of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA. This guideline was published in the Federal Register on February 23, 1996 (61 FR 7006) and is applicable to drug and biological products. Although this guideline does not create or confer any rights for or on any person and does not operate to bind FDA or the industry, it does represent the agency's current thinking on the production of r-DNA derived protein products. For additional copies of this guideline, contact the Drug Information Branch, HFD-210, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20857 (Phone: 301-827-4573) or the Manufacturers Assistance and Communication Staff (HFM-42), CBER, FDA, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the offices in processing your request. An electronic version of this guidance is also available via Internet using the World Wide Web (WWW) (connect to the CDER Home Page at http://www.fda.gov/cder
and go to the Regulatory Guidance section).