FDA Draft Guideline on reporting Changes to an approved Application

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

It was 1997 when the FDA published their "Guidance for Industry: Changes to an Approved Application: Biological Products". The Document was supposed to assist marketing authorisation holders (MAHs) and manufacturers in classifying and reporting on changes in the chemistry, production and control of approved products as per CFR 601.12.

The new document on this topic published on 21 December, 2017, is a revised version of the almost 20 year old guideline and is, in its final version, supposed to replace the old guideline.

There are various reasons why a manufacturer of biological medicinal products may be forced to change the chemical composition, production process or control strategy of an approved product. This may also affect the equipment used, facilities or plants or the responsible personnel. Manufacturers need to inform the competent authority about such changes. The requirements for "Approved Biological Applications (BLA)" must be considered as well as the requirements of other regulations like "current good manufacturing practice (cGMP)" as per CFR Section 501 while doing so.

Currently the change notifications of the past years considering modern principles of risk assessment as per "Guidance for Industry: Q9 Quality Risk Management (Ref. 3)" are evaluated comprehensively. Then the present draft guideline is supposed to provide updated support for users. For that purpose a number of examples for changes were added to aid the user when it comes to the classification of post-approval changes and their submission.

The following products are within the scope of the new guidance document:

• Vaccines
• Allergenic products
• Plasma-derived products (e.g., albumin, immunoglobulins, clotting factors, fibrin sealants, proteinase inhibitors, etc.)
• Antitoxins, antivenins, and venoms
• Naturally-derived protein products (e.g., enzymes, toxins, etc.)
• Cellular, gene and cell-based gene therapy products
• In vitro diagnostics (IVDs) regulated under the PHS Act (e.g., blood donor screening assays, etc.)
• Other biological products licensed under the PHS Act subject to exceptions listed below

Comprehensive information can be found directly in the draft guideline "Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products".