What Is the BLA Process? The BLA submissionrequ

What Is the BLA Process?

The BLA submissionrequirements can differ for each product and applicable regulation (i.e., 21 CFR parts 600, 601 and 610), but the application process is generally the same, as outlined below:

Apply for a BLA – The party responsible for the regulatory compliance of a biologic must communicate to the FDA its intention to apply for a license. This can include forming a review committee to meet with the FDA; scheduling a bioresearch monitoring inspection; and/or submitting a manufacturing validation plan, all prior to submitting the BLA itself.

Submit a Form FDA 356h – According to the Electronic Common Technical Document (eCTD) submission requirement, a BLA must be submitted in electronic format using the current FDA fillable form and electronic signatures, unless an exemption is granted.

Await FDA Review – The FDA reviews the BLA submission for completeness and requests any missing information from the applicant. If the information is not provided, is incomplete, or if the biologic is not ready for approval, a Refuse to File (RTF) may be issued. If the BLA is approved, the FDA will issue an approval letter authorizing the manufacturer to distribute the product.

Implement Agreements or Commitments – If the approval letter includes any agreements or commitments, the applicant must address them according to the FDA’s requirements.

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