Variation submission

Regulatory
1

dear All,
Good day.
I find this group very useful. thank you for your full support.
please help me in following issues:

" please help me with reference (link or guideline name) of ICH or WHO or FDA Variation submission guideline to regulatory bodies. variation means changes in formulation, tablet color, shape etc".

please help me with reference .
thank you.

Regards
Sharmin

2

  • Guidance for Industry, Immediate Release Solid Oral Dosage Forms, Scale-Up and Post approval Changes. CDER, FDA.

  • WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report, WHO guidelines on variations to a prequalified product.

3

For EU: Variations including extensions of marketing authorisations | European Medicines Agency (EMA)

For US: SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation | FDA

Hope this will help!!!