Chemistry manufacturing controls CMC Regulatory Affairs

Chemistry, manufacturing, and controls (CMC) regulations are a critical part of the drug development path and the ongoing production and distribution of pharmaceutical therapies.

Key Highlights

As drug laws have evolved, many advantages have emerged, which have made a positive impact on the industry as a whole - Learn how PRA is navigating Global Regulatory CMC Processes During Covid-19

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History assures us that we meet public health challenges through industry and regulators collaborating more closely, and enacting regulations that allow for future improvements and flexibility to meet future crises.

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PRA Insights Team
PRA Insights Team
By:Phil Simonson, VP Global Regulatory Affairs CMC

If you follow the history of US and global drug laws over the last century, you see that many changes to CMC regulations have occurred in response to major public health crises. For example, the US Federal Food, Drug, and Cosmetic Act of 1938 was prompted by the introduction of a new pediatric formulation of sulfanilamide, which contained a poisonous solvent, diethylene glycol. In addition, the tamper-resistant packaging requirements of 1982, which required much stricter packaging regulations, resulted from deadly tampering of Tylenol capsules.

As drug laws have evolved, many advantages have emerged, which have made a positive impact on the industry as a whole:

  • more rapid access to life-saving medicines with a focus on safety
  • global access to cheaper medicines
  • faster and more predictable regulatory pathways to new drug approvals
  • significant improvements in collaboration between industry and global regulatory health authorities worldwide
  • focus on innovation and flexibility.

Quick response to Covid-19

The momentum gained over the past 10-15 years alone has allowed both sponsors and regulators to respond quickly to the COVID-19 pandemic. Because the accelerated drug development pathways and regulatory flexibility are already in place, our global industry has been able to get a large number of therapeutics (~250) and vaccines (~180) into the collective global pipeline, which shows the positive effects of these changes. The former regulatory infrastructure would not have been able to handle this type of volume.

As we face COVID-19 globally, we again see examples of unprecedented regulatory flexibility. The European Medicines Agency (EMA) issued on 10 April 2020 their Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During The Covid-19 Pandemic, stating that an exceptional change management process (ECMP) will enable drug makers to both source materials and active substances from suppliers not specifically mentioned in the marketing authorization. In addition, it allows for the use manufacturing sites or sites responsible for quality control that are not specifically mentioned in the marketing authorization if necessary to prevent/mitigate supply shortages in the EU.

CMC team flexibility

Just as flexibility within regulatory agencies is critical to managing the manufacturing supply chain during this difficult time, so is flexibility within sponsor CMC teams. Current conditions make it more challenging to do our jobs effectively, as many teams are now remote and activities, such as in-person visits to manufacturing sites to monitor equipment and facility conditions, are significantly reduced. We must review our own processes and implement changes to keep us efficient and compliant. CMC teams should:

  • Ensure open communication pathways

    Our reliance on global stakeholders has not changed, but where and when we can reach them has changed. We need to establish a regular communication cadence, where all members of our team, including contractors, have a way to share information and progress.

  • Track critical timelines

    In a remote world, it can be harder to keep track of project progress. Consider implementing an online project management tool to ensure that handoffs are tracked and the next responsible person is notified of their task. Compromised timelines can lead to unplanned expenses and penalties.

  • Implement virtual tools

    Instead of relying on in-person facility visits, schedule video walkthroughs or request Matterport 3D tours.

  • Consider contracting global remote workers

    Whether your own team has been downsized due to economic conditions, or you just need more hours in the day, a contract workforce can help. CROs have the ability to recruit from all over the US and EU without needing new hires to relocate. This gives CROs access to a much larger pool of candidates than any one geographic region or city would normally allow. Because of this flexibility, CROs can quickly acquire and retain great talent.

Emerging into a new future

There is no doubt that public health crises present challenges to our normal processes and workflow. However, history assures us that we meet these challenges through industry and regulators collaborating more closely, and enacting regulations that allow for future improvements and flexibility to meet future crises. When we successfully emerge on the other side of this pandemic, we will emerge into a new future.

PRA’s Global Regulatory Affairs team strategically shortens approval timelines and efficiently gets your products to market and beyond. We are committed to keeping our clients abreast of changes in the regulatory landscape to ensure patients are protected and your goals stay on track.

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