The FDA’s latest regulations introduce a risk-based inspection model to streamline biologics oversight, improving efficiency and flexibility in life sciences while ensuring safety, purity, and potency. Learn more about the FDA’s landmark changes.
Learn how this monumental change is going to re-imagine the process of securing and streamlining.
The Future of Regulations
The FDA has historically failed to enforce inspection and regulatory compliance within the life science industry, but that all changed with the latest final rule.
This is a step forward towards evolving industry dynamics to foster innovation data integrity, safety as well as purity and potency for biological products being administered in humans.
Making Inspection Mandatory
Revisions to time of inspection requirements in Sec. 600.21 (21 CFR 600.21).
Under existing regulations, these establishments must be inspected biennially if they were registered as drug or device establishment. Now, through FDASIA and the FDA Reauthorization Act of 2017 (FDARA), these biennial inspections have been replaced with a risk-based inspection schedule.
Now that Food Safety and Inspection Service (FSIS) will use a risk-based model, resources can be divvied out in ways to best tailor the inspection schedule around the unique needs and risks of each individual establishment.
The FDA is removing the rigid biennial mandate to better accommodate that some establishments might need inspections more or less often, based on their unique situations.
The final rule also removes antiquated sections related to inspectional notice and the time of pre-licensure reinspections for biological product establishments ( 21 CFR 600.21).
Such outdated provisions have been superseded by other FDA procedures and manuals. The FDA wants to sharpen its approach on specific aspects of safety and efficacy as it adapts with the industry.
In addition, the final rule eliminates Sec. 600.22 — Duties of an FDA inspector. The agency has determined that the requirementsunder 600.22(a) through (h) are unnecessary because all those duties are encompassed in section 704 by statute. This will not only impact the legitimacy of inspections, but it does make things precise.
Regulatory Innovation as a Change
The FDA is adopting a more flexible approach to regulating. This allows regulatory bodies to review current guidelines and amend as needed, ensure they are meeting the public health needs and keeping up with industry evolution.
Legal Authority and Compliance
The FDA takes the action under the legal authority provided to it by its Public Health Service Act (PHS Act) and Federal Food, Drug, and Cosmetic Act (FD&C).
Through these laws, FDA is enabled to promulgate and enforce regulations on licensed biological products according to the safety, purity and potency testing specifications as well as quarantining from one state into another when communicating disease outbreak occurs.
Conclusion
This final rule by the FDA is a major milestone in advancing and simplifying life science industry regulation.
The FDA is prepared to improve flexibility and efficiency of the regulatory process without compromising public health by implementing a risk-based inspection approach that removes archaic provision, all while staying aligned with changing industry dynamics.
The regulatory change is a testament to the FDA’s commitment to innovation and greater compliance with quality in life science.
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