Post-approval changes in pharmaceutical companies refer to any modifications made to a drug product or its manufacturing process after receiving regulatory approval. These changes need to be reported to regulatory authorities like the US FDA, EMA, MHRA, or CDSCO, depending on the market.
Types of Post-Approval Changes:
Administrative Changes
- Change in company name, address, or authorized person.
Manufacturing Changes
- Change in manufacturing site.
- Change in batch size.
- Change in manufacturing process.
- Change in equipment or production scale.
Formulation Changes
- Change in excipients (inactive ingredients).
- Minor adjustments in composition.
Packaging Changes
- Change in packaging material or design.
- Change in container closure system.
Labeling Changes
- Update in product information or warning labels.
- Change in product artwork.
Analytical Method Changes
- Change in testing method or specifications.
Stability Changes
- Change in shelf-life or storage conditions.
Safety & Efficacy Changes
- New clinical data or indications.
- Changes in dosage or administration.
Regulatory Classification of Changes
Based on the potential impact on product quality, safety, or efficacy, changes are categorized as:
Approval Process:
- Impact Assessment
- Regulatory Filing Preparation
- Submission to Authority
- Regulatory Review
- Approval or Rejection Notification
Guidelines for Post-Approval Changes
- US FDA: 21 CFR 314.70
- EMA: Variation Regulation (EC) No 1234/2008
- WHO: Guidelines on Post-Approval Changes
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