guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical Producta variati<strong>on</strong> can be approved by NDA. Four categories of changes that requireapplicati<strong>on</strong> for variati<strong>on</strong>s have been provided in the <str<strong>on</strong>g>guidelines</str<strong>on</strong>g>. These includenotificati<strong>on</strong>s, minor changes, major changes and changes that make a newapplicati<strong>on</strong>.Changes are classified as major <strong>on</strong>ly in those instances where the level ofrisk is c<strong>on</strong>sidered <strong>to</strong> be high and it is deemed necessary <strong>to</strong> provide NDA withadequate time for an assessment of the supporting documentati<strong>on</strong>. Decisi<strong>on</strong>s<strong>on</strong> such changes shall be made by the NDA Licensing and Amendments ReviewCommittee (LARC).Particular circumstances are identified where lower reporting requirements (AN,IN or Vmin) are possible.The change categories are organized according <strong>to</strong> the structure of the Comm<strong>on</strong>Technical Document (CTD). Specific CTD secti<strong>on</strong>s have been identified forindividual data requirements in order <strong>to</strong> assist in the filing of documentati<strong>on</strong>.In additi<strong>on</strong>, the guideline assists in understanding the possible c<strong>on</strong>sequencesof the listed changes, and may be useful as a risk management <strong>to</strong>ol <strong>to</strong> promoteor enhance best practices within organizati<strong>on</strong>s.The Guideline is an administrative instrument and allows for flexibility inapproach. Alternate approaches <strong>to</strong> the principles and practices described inthis document may be acceptable provided they are supported by adequatejustificati<strong>on</strong>. Alternate approaches should be discussed in advance with NDA<strong>to</strong> avoid the possible finding that applicable regula<strong>to</strong>ry requirements have notbeen met.As a corollary <strong>to</strong> the above, it is equally important <strong>to</strong> note that NDA reservesthe right <strong>to</strong> request informati<strong>on</strong> or material, or define c<strong>on</strong>diti<strong>on</strong>s not specificallydescribed in this guideline, in order <strong>to</strong> allow for adequate assessment of safety,efficacy or quality of the <strong>pharmaceutical</strong> <strong>product</strong>. NDA is committed <strong>to</strong> ensuringthat such requests are justifiable and that decisi<strong>on</strong>s are clearly documented.Doc. No.: DAR/GDL/005 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 2 of 70