Biologic License Establishment

All pharmaceuticals marketed in the United States, including biotechnology products, must be proven safe and effective for their intended use. The FDA requires that all recombinant proteins and other biotechnology products be produced by a manufacturer holding a certified Biologic License Establishment (BLE). The pharmaceutical company is required to collect safety and efficacy data, first in animal studies and subsequently in clinical trials. This information is submitted in a new drug... 

Change in the fashion biologicals regulated (elimination of the Establishment and Product licenses, both replaced with a Biological License Application or BLA). 

Food and Drug Administration. Implementation of Biologies License Elimination Of Establishment License and Product License Public Workshop, FDA, Rockville, MD, 1998. 

Application and approval process NDA (New Drug Application) PLA (Product License Application) ELA (Establishment License Application) BLA (Biologic License Application)... 

QA/QC specifications are summarized in the Chemistry, Manufacturing, and Contois (CMC) section and in the Established Description sections of the Biologies License Application (BLA) for every recombinant and other biologic product. Additional details on FDA requirements for product specification and QA/QC standards are found in the Guidance for Industry (FDA website— www.fda.gov/cber/guidelines.htm). 

FDA. Biological Products Regulated under Section 351 of the Public Health Service Act Implementation of Biologies License Elimination of Establishment License and Product License, 1999. http //www.fda.gov/cber/rules/elapla.pdf... 

The Medical Device User Fee and Modernization Act (MDUFMA) amended the Federal Food, Drug and Cosmetic Act to provide the FDA with important new responsibilities, resources, and challenges [7]. The MDUFMA has three significant provisions (1) Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Biological License Applications (BLAs), certain supplements, and 510(k)s are now subject to fees. (2) Establishment inspections may be conducted by... 

A system for retaining reserve samples of APIs should be established and followed. This system should ensure that reserve samples are retained for an appropriate length of time after approval, termination, or discontinuation of an investigational new drug application (IND), a new drug application (NDA), or biologies license application (BLA). Additional reserve samples should be maintained for API batches used in pivotal toxicological and/or biobatches. 

Figure 7.9 Outline of requirements for a Veterinary Biologies Establishment License.

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