Egypt Explains Submission Status for Parenteral Biologicals Changes
Egypt’s Central Administration for Pharmaceutical Affairs has issued guidelines for determining when a change in parenteral biological preparations should be submitted as a new application or a variation.
New applications are required for the following modifications:
- Switches from single-dose to multi-dose or vice versa;
- Changes in the strength of the formulation; and
- Changes to, or addition of, a dosage form.
Revisions to a biologic’s container, pack size, fill volume or fill weight where the dosage strength and composition aren’t altered are variations, according to the recently posted guideline.
Changes in route of administration that don’t alter the composition or specifications of the finished product also may be submitted as variations, while revised routes of administration that tweak the composition and/or specifications are considered a new drug.
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