“Discover strategies for pharmaceutical companies to navigate post-pandemic regulations. Learn about FDA EUA processes, compliance, inspections, and quality management for successful product approval.”
The Impact of COVID-19 on Pharmaceutical Regulations
The pharmaceutical industry’s regulation has changed due to the effects of COVID-19 across many areas, reshaping how regulatory agencies approach and accept new treatments in an emergency. The FDA EUA process is activated in response to the public health emergency declared approximately three years ago and seeks to spur on the vaccine and treatment efforts developed by those who could provide help fighting it.
The industry was responsive to this challenge and took drastic organizational steps away from its usual routines. At the same time, regulators adjusted rapidly to varying modalities under immense stress while prioritizing safety and quality.
Thus far the EUA process has been employed for over 750 products spanning diagnostic tests, COVID vaccines, drugs/biologics/other therapeutic products, devices and more versus under 40 (one can count them on one hand) in the previous sixteen years. Examples involving Exceptional Utilization Authorization EUA for vaccines helping to control COVID 19 pandemic.
While things start returning back to normal after COVID-19, Government and FDA said that they expect the pandemic to be over and confirmed the end of i PUBLIC HEALTH EMERGENCY (PHE) as we know! The announcement is made to provide plenty of time for companies to transition so that supplies can remain available without interference. Such a change will be impactful for the businesses that have been granted EUA status, and they must ready themselves to go through an end-to-end process of waving off their immunity under this waiver.
FDA Communications to Preserve U.S. Product Distribution
The FDA also expects those granted EUAs for COVID products during the PHE to communicate plans for these interventions through termination of the PHE. The plan should state whether a sponsor intends to seek withdrawal of the EUA or submit an NDA/BLA. Any product receiving emergency use authorization will have to go through the standard FDA approval process before it can be marketed in the U.S.
It is crucial to submit this plan so that products can continue to be distributed in the US and companies are well advised now to start preparing for submitting full applications including clinical trial data, manufacturing processes and quality control information for a review by the FDA. It may require some time to get an approval, and all firms must be sure that they have sufficient resources available on the step. The application process is simple.
Steps before on-site surveys
The FDA is on the verge of more on-site Inspections in its Approval Process. U.S. regulatory authorities have included quality assurance as a long-term initiative. Using the knowledge gained in those pharmaceutical cGMP workshops to further improve safety and integrity of supply chains through tighter control post-COVID.
As a result, several similar but separate legislative efforts are being pursued by Congress, one of which would require more frequent and precautionary risk-based inspections—including the expansion of unannounced foreign inspections. These inspections cover manufacturing practices and shipments (Good Practice), treatment plans handling and medical data quality management systems as well as organization of the clinical trial itself from packing to safety reports up until complete responsibility for monitoring system performance.
Navigation: Drug Company Partnerships. Maintaining inspection readiness is a major expectation for every drug company, requiring more rigor from companies with little prior history of compliance issues or other forms of challenges. If you fail, the product will be dropped.
Both aspects suggest that companies need to prioritize inspection readiness and maintain a dynamic effort on the ongoing regime of controls. with an adage towards high-quality processes & deliverables.
Having a culture of quality is key to streamlining approval, lowering the burden or costs associated with running inspection-ready operations and developing positive relationships where your regulator trusts you.
Pharmaceutical Company Regulatory Compliance Support
Ending the EUA pathway would make pharmaceutical companies hold regulatory compliance as a higher impetus and gear for stringent scrutiny during full FDA approval. To this end, companies may look to regulators as their allies and partners in order that they can transition from a compliance-driven approach (i.e. the current annual process) to evidence-based regulatory decision making,
The fate of many pharmaceutical companies has been sealed by the cessation of public health emergencies, but BioBoston Consulting’s Strategic Compliance team can provide broad assistance.
FDA Communications and Product Distribution
For companies receiving EUA status, an additional point of reflection is the requirement to continue collecting and analyzing further data as part of evidentiary development for approval. Although the EUA process allowed for accelerated approval with some data, more rigorous data are necessary to support safety and efficacy claims in a standard FDA approval. So, businesses will still have to track data and analyze it the right way.
Finally, the termination of EUA status for any COVID-related products and the end of a public health emergency does not mean that it is no longer termed as pandemic. Even more fundamentally, the COVID-19 virus remains a danger
The expiry of the public health emergency has broader implications on FDA’s regulatory approach in US beyond reverting status to companies enjoying EUA. As noted above, the spotlight on supply chain safety and security will be intensified under a restored commitment to regulatory compliance leading to more extensive inspections.
Regulatory Compliance Support for Pharmaceutical Companies
Additionally, the FDA is set to restart its routine pre-approval inspection program which was on hold during Covid. These are routine inspections that help confirm compliance with Good Manufacturing Practices (GMPs) and related regulations/regulatory agreements ensure both the quality control process checks in place for assuring drugs or biologics meet specifications.
Companies must therefore be well-prepared for such inspections and comply with all legal requirements. This involves keeping precise records, setting up stringent quality control standards and establishing strong supply chain management systems.
The Future of Regulatory Compliance in the Pharmaceutical Industry
The end of the public health emergency also provides an opportunity for companies to take stock of their regulatory compliance programs and determine where they may need some work. For instance, improving training programs or investing in technology to increase quality control and supply chain management can certainly fall into the effective compliance category as well as developing better communication processes with regulatory bodies.
Working with a regulatory compliance consultant such as Bioboston Consulting is an essential tool for companies adjusting to the new post-Pandemic regulation. BioBoston Consulting has a Strategic Compliance Consulting team who can help you navigate the regulatory compliance waters, including clinical data review and maintenance of GCP compliant processes.
Conclusion: Navigating the New Regulatory Landscape
Bioboston Consulting can also assist in the design and construction of robust quality management systems to support adherence with all regulations. It involves creating strong procedures for managing your supply chain, ensuring quality standards are met and keeping accurate records that ensure you meet government regulations.
So, in summary, when the public health emergency ends and all these COVID-related products are no longer approved under EUA (regular approval) this is going to cause a great change for US regulatory. Companies should get ready for the rise of regulation and make them all obey it.
Partnering with a regulatory compliance expert such as Bioboston Consulting provides companies an effective alternative to navigate the post-pandemic regulatory environment successfully. Companies can take proactive measures to address the end of the public health emergency in order keep their products available on the US market, as well and set themselves up for success within pharmaceutical industry into its future.
Reach out to BioBoston Consulting today or visit our site for more information on how we can help your organization.
