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- Title
Submission pathway for post-approval changes in Japan.
- Authors
Abhishek, B. V.; Balamuralidhara, V.; Kumar, T. M. Pramod
- Abstract
Post-approval changes are the changes made to the drug product which is already approved by the regulatory agency of any country. Changes or variations in any information relating to licensed or approved drug products, including information relating to the composition of listed drugs or other aspects of their manufacture and the labeling of the drugs, shall be reported to the agency forth with and the adjustment or modification shall not take place until approved by the agency.. Chemistry, manufacturing, and controls (CMC) changes are inevitable due to many reasons, including changing needs, new findings, and continuous improvement. Therefore, regulations require that all changes be evaluated carefully and follow the proper regulatory path for implementation, regardless of whether it is an investigational or a commercial product. Failure to comply with the regulatory requirement for post-approval CMC changes can potentially lead to "misbranded or adulterated" status for a given product. This should be taken very seriously for marketed products because of the potential safety/efficacy impact for the vast number of patients as well as legal, regulatory and business impact for the sponsor. Changes occur to have business continuity in case of quality problems, to maintain the economy, process improvisation, alternate addition of sources, or exclusion. The applicant of registered generics who intend to make post-approval changes should follow the guidance or regulation in accordance with the agency which is different for each country. The changes can be major, moderate, or minor depending on the changes likely to affect the quality, safety, and efficacy of the product. Irrespective of the category of the changes, every change is to be brought to the notice of the regulatory authorities in stringent, structured, and stipulated format that is recommended for the regulatory advancements.
- Subjects
JAPAN; DRUG labeling; COMMERCIAL products; GOVERNMENT agencies; DRUG factories
- Publication
Drug Invention Today, 2020, Vol 14, Issue 2, p268
- ISSN
0975-7619
- Publication type
Article