Institute of Good Manufacturing Practices India
Global accredited training provider
Approved by Quality Council Of India (QCI), Government of India
An ISO 9001:2008 Certified Organisation
Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
New Delhi | Noida | Hyderabad | Lucknow

Trusted by training participants in over 20 countries


New policy with respect to grouping of supplements for chemistry, manufacturing and controls (CMC) changes released by FDA

The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) has released a new document with respect to grouping of supplements and their submission concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant. The goal of the new policy is to make the process more efficient and consistent when reviewing grouped supplements.

The term “grouped supplements” is used to describe two or more supplements reviewed and processed using the procedures set forth in the new document FDA however makes it clear that supplements cannot be grouped if submitted by a different applicant or if the supplements provide for different CMC changes.


Supplements can be grouped when the following criteria are met:
• The cover letter for the supplements clearly states the purpose of the proposed CMC changes and indicates that the supplement is one of multiple submissions for the same change.
• Each supplement includes a list of the application numbers (NDA, BLA, and ANDA, as appropriate) and identifies the drug products that will be covered by the CMC changes.
• The supplements have the same submission date on Form FDA 356h. However in certain cases wherein the above criteria is not met, FDA may allow grouping of the supplements if it is advantageous to the review process.


IGMPI

More

Contact Us