US FDA suggests annual reporting for low-risk manufacturing changes 27 June 2010 Vibha Sharma
The US Food and Drug Administration is proposing to relax its policy on the submission of supplementary applications for minor and incremental changes to drug sponsors' manufacturing processes and controls.
Under the new policy, such changes, which the agency says are low-risk, would be submitted in annual reports to the agency. The suggestions are contained in new draft guidance that describes the chemistry, manufacturing and controls post-approval manufacturing changes the FDA has determined "will likely present minimal potential to have adverse effects on product quality" and may be reportable in annual reports.
The guidance is relevant for holders of new drug applications and abbreviated new drug applications. It does not, however, apply to positron emission tomography正电子发射计算机断层显像drug products. Stakeholders have until 23 September to submit feedback.
The initiative builds on a 2004 report by the agency in which it expressed the need for implementing a co-operative, risk-based approach for pharmaceutical manufacturing, in order to keep pace with the many advances in quality management practices and to more effectively allocate the FDA's limited regulatory resources.
In a Federal Register notice announcing the availability of the draft guidance, the agency notes that the number of CMC manufacturing supplements for NDAs and ANDAs has continued to increase over the past several years. Many of the changes being reported, the FDA said, "present very low risk to the quality of the product and do not need to be submitted in supplements".
The FDA has drawn up a list of post-approval manufacturing changes that may be considered to have a minimal potential for an adverse effect on the identity, strength, quality, purity or potency of the drug product and, therefore, may be classified as a change reportable in an annual report (eg, notification of a change after implementation) rather than in a supplement.
The list, attached as an appendix to the draft guidance, has been drawn up from the CMC changes previously submitted as manufacturing supplements to the FDA and were determined to be low-risk. It contains examples of CMC changes relating to: components and composition; manufacturing sites; manufacturing processes; specifications; container/closure systems; and other miscellaneous issues.
The guidance, if finalised, would mean that some changes, for which sponsors are currently submitting manufacturing supplements, may be notified to the FDA in annual reports only. The sponsor, the FDA says, would have to describe each change in an annual report "in enough detail to allow us to quickly determine whether the appropriate reporting category has been used". If the submitted change is inappropriate for an annual report, the applicant would be notified of the correct category and additional information may be requested.
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