[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.2]

[Page 21-23]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 601.2  Applications for biologics licenses; procedures for filing.


    (a) General. To obtain a biologics license under section 351 of the 
Public Health Service Act for any biological product, the manufacturer 
shall submit an application to the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research (see mailing addresses in Sec. 600.2 of this chapter), on 
forms prescribed for such purposes, and

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shall submit data derived from nonclinical laboratory and clinical 
studies which demonstrate that the manufactured product meets prescribed 
requirements of safety, purity, and potency; with respect to each 
nonclinical laboratory study, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance; 
statements regarding each clinical investigation involving human 
subjects contained in the application, that it either was conducted in 
compliance with the requirements for institutional review set forth in 
part 56 of this chapter; or was not subject to such requirements in 
accordance with Sec. 56.104 or Sec. 56.105, and was conducted in 
compliance with requirements for informed consent set forth in part 50 
of this chapter. A full description of manufacturing methods; data 
establishing stability of the product through the dating period; 
sample(s) representative of the product for introduction or delivery for 
introduction into interstate commerce; summaries of results of tests 
performed on the lot(s) represented by the submitted sample(s); 
specimens of the labels, enclosures, and containers, and if applicable, 
any Medication Guide required under part 208 of this chapter proposed to 
be used for the product; and the address of each location involved in 
the manufacture of the biological product shall be listed in the 
biologics license application. The applicant shall also include a 
financial certification or disclosure statement(s) or both for clinical 
investigators as required by part 54 of this chapter. An application for 
a biologics license shall not be considered as filed until all pertinent 
information and data have been received by the Food and Drug 
Administration. The applicant shall also include either a claim for 
categorical exclusion under Sec. 25.30 or Sec. 25.31 of this chapter 
or an environmental assessment under Sec. 25.40 of this chapter. The 
applicant, or the applicant's attorney, agent, or other authorized 
official shall sign the application. An application for any of the 
following specified categories of biological products subject to 
licensure shall be handled as set forth in paragraph (c) of this 
section:
    (1) Therapeutic DNA plasmid products;
    (2) Therapeutic synthetic peptide products of 40 or fewer amino 
acids;
    (3) Monoclonal antibody products for in vivo use; and
    (4) Therapeutic recombinant DNA-derived products.
    (b) [Reserved]
    (c)(1) To obtain marketing approval for a biological product subject 
to licensure which is a therapeutic DNA plasmid product, therapeutic 
synthetic peptide product of 40 or fewer amino acids, monoclonal 
antibody product for in vivo use, or therapeutic recombinant DNA-derived 
product, an applicant shall submit a biologics license application in 
accordance with paragraph (a) of this section except that the following 
sections in parts 600 through 680 of this chapter shall not be 
applicable to such products: Sec. Sec. 600.10(b) and (c), 600.11, 
600.12, 600.13, 610.11, 610.53, and 610.62 of this chapter.
    (2) To the extent that the requirements in this paragraph (c) 
conflict with other requirements in this subchapter, this paragraph (c) 
shall supersede other requirements.
    (d) Approval of a biologics license application or issuance of a 
biologics license shall constitute a determination that the 
establishment(s) and the product meet applicable requirements to ensure 
the continued safety, purity, and potency of such products. Applicable 
requirements for the maintenance of establishments for the manufacture 
of a product subject to this section shall include but not be limited to 
the good manufacturing practice requirements set forth in parts 210, 
211, 600, 606, and 820 of this chapter.
    (e) Any establishment and product license for a biological product 
issued under section 351 of the Public Health Service Act (42 U.S.C. 201 
et seq.) that has not been revoked or suspended as of December 20, 1999, 
shall constitute an approved biologics license application in effect 
under the same terms and

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conditions set forth in such product license and such portions of the 
establishment license relating to such product.

[64 FR 56450, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]