FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Revises Draft Guidance for Immunoglobulin Biologic Applications

Jan. 10, 2017

The EMA published a third revision to its guideline for sponsors seeking authorization for human normal immunoglobulin for intravenous use, covering biological data, pharmacokinetics, clinical trials and patient follow-up, as well as changes in the manufacturing process of previously authorized products.

It replaces the previous version, and now includes recommendations for multifocal motor neuropathy and chronic inflammatory demyelinating polyradiculoneuropathy, and rewords the secondary immunodeficiencies section.

The guideline was adopted by the EMA’s Committee for Medicinal Products for Human Use Dec. 15, and will be open to public consultation from Jan. 1 through March 31, 2017.

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