Biologic License Application licensing process

The regulatory process is the filing of an IND for clinical trials. At the conclusion of clinical trials, the Sponsor files a Biological License Application (BLA) for marketing approval. The CBER evaluates a biologic in terms of risk versus benefits before approving it for marketing. 

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

Center for Biologies Evaluation and Research (CBER). Manual of Standard Operating Procedures and Policies, SOPP 8401. Administrative Processing of Biologies License Applications, Feb. 22,1998. 

A Biologies License Application (BLA)-enabling process is typically used for the manufacture of clinical Phase III material and the full-scale market supply after launch out of the final plant. This process... 

Similar to the requirements for small molecules, at least three batches of drug substance of pilot or full scale batch size and representative of the process used in pre-clinical, clinical, and proposed manufacturing scale should be studied. If pilot scale lots are used in the stability study for the Biologies License Application (BLA), a commitment must be made to place the first three commercial batches on stability. 

Health, Environmental, Quarantine and Other Regulations Many countries have strict regulations designed to protect the ecosystem and agrochemical business. For example any matrix material derived from pork, beef, sheep or horse tissue has to be accompanied with a Veterinary Certificate confirming that the matrix material is free of certain specified diseases before it can be imported into the EU. The Australian import restrictions are even tougher and require the importer to obtain prior permission to import plant and animal materials and products derived from biological materials. To get an import license it is necessary to complete an application, which includes information from the producer about the actual production process used to prepare the matrix ... 

For all other biological products, sponsors must submit two applications, an establishment license application (ELA) and a product license application (PLA). Both submission processes (BLA or ELA/PLA) may require nonclinical and clinical data, chemical and biological information, and information on the product manufacturing process and facility. Ultimately, the single-application... 

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