Post-Approval Changes to NDA and ANDA ppt pdf

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Post-Approval Changes to NDA and ANDA ppt pdf

Holders who intend to make post-approval changes to NDA and ANDA should follow in accordance with section 506A of the Federal Food, Drug, and  Cosmetic Act. An applicant must provide Specific information to assess the effect of the change on the identity, strength,  quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.

Recommendations are provided for postapproval changes in:

(1) Components and composition

(2) Manufacturing sites

(3) Manufacturing process

(4) Specifications

(5) Container closure system

(6) Labeling

(7) Miscellaneous changes and

(8) Multiple related changes

An applicant must provide Specific information to assess the effect of the change on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug.

Reporting Categories for Post-Approval Changes to NDA and ANDA

  • Major Change: Substanial Potential
  • Moderate Change: Moderate Potential
  • Minor Change: Minimal Potential

To have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.

Major Change

It requires the submission of a supplement and approval by FDA prior to distribution of the drug product made using the change. This type of supplement is called and should be clearly labeled, a Prior Approval Supplement.

Moderate Change

One type of moderate change requires the submission of a supplement to FDA at least 30 days before the distribution of the drug product.

This type of supplement is called, and should be clearly labeled, a Supplement – Changes Being Effected in 30 Days.

In another type, FDA may identify certain moderate changes for which distribution can occur when FDA receives the supplement. This type of supplement is called, and should be clearly labeled, a Supplement – Changes Being Effected.

Minor Change

A minor change is a change that has minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.

The applicant must describe minor changes in its next Annual Report.

General Requirements for Post-Approval Changes to NDA and ANDA

A supplement or annual report must include a list of all changes contained in the supplement or annual report. On the list, FDA recommends that the applicant describe each change in enough detail to allow FDA to quickly determine whether the appropriate reporting category has been used.

An applicant making a change to an approved application under section 506A of the Act must also conform to other applicable laws and regulations, including current good manufacturing practice (CGMP) requirements and applicable regulations of the Code of Federal Regulations.

Assessing the effect of manufacturing changes

Assessment of the Effects of the Change

The holder of an approved application under section 505 of the Act must assess the effects of the change before distributing a drug product made with the manufacturing change

Equivalence

When testing is performed, the applicant should usually assess the extent to which the manufacturing change has affected the identity, strength, quality, purity, and potency of the drug product.

Adverse Effect

Some manufacturing changes have an adverse effect on the identity, strength, quality, purity, or potency of the drug product.

If an assessment indicates that a change has adversely affected the identity, strength, quality, purity, or potency of the drug product, FDA recommends that the change be submitted in a prior approval supplement regardless of the recommended reporting category for the change.

For more information download Post Approval Changes to NDA and ANDA PDF

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