Regulatory Considerations for Pharmaceutical Product Lifecycle Management

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. Recent new guidance, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry, Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) May 2021 ICH” now applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization (MA). This guidance focuses on the commercial phase of the product lifecycle and applies to pharmaceutical drug substances and products – both chemical and biological – that require a marketing authorization.

What does this mean for your organization?

The guidance provides a framework for:

1. Managing post-approval chemistry, manufacturing, and controls (CMC) changes to make them more predictable and efficient
2. Managing regulatory submissions through increased product and process knowledge
3. A better understanding of which post-approval changes should result in a regulatory submission
4. The definition of the levels of reporting categories for such changes.

The Impact of This Guidance

Regulatory Pathways

Products affecting regulatory pathways are typically already approved. Because of this, the guidance poses no impact on regulatory pathways. However, this is a time in the process for research staff to analyze the change that will happen and its impact. Application of the new guidance should enhance the R&D industry’s ability to manage CMC changes more effectively and with less need for regulatory oversight prior to implementation.

With this knowledge, companies could reduce the number of post-approval submissions to the Marketing Authorization Application (MAA) and are incentivized to pursue continual improvement by knowing when and where there is opportunity for greater flexibility in making post-approval changes.

New Established Conditions

The establishment of a new concept of Established Conditions (ECs) provides a clear understanding between the marketing authorization holder (MAH) and regulatory authorities regarding the elements to assure product quality and those that involve regulatory communications if changed. ECs are identified as well as what information is designated as supportive information that would not involve regulatory communications.

Post Approval Change Management Protocol

The Post Approval Change Management Protocol (PACMP) is a regulatory tool that provides predictability regarding the information required to support a CMC change and the type of regulatory submission based on prior agreement between the MAH and regulatory authority. This mechanism enables the planning and implementation of future changes to ECs in a more efficient and predictable manner. The Product Lifecycle Management (PLCM) document serves as a central repository for ECs and the associated reporting category for changes made to ECs. The document also captures how a product will be managed during the commercial phase of the lifecycle, including relevant post-approval CMC commitments and PACMPs.

Go-to-market Strategy

If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. However, obtaining approval will take a bit of time – up to a year. Knowing this, organizations wanting to implement a change will need to plan well in advance.

For example, if an organization wants to add an additional production line in a plant to increase manufacturing, they will need to think of a timeline for adding that production line and work backward from there. Whenever they plan to build, they would need to add on at least a year for the FDA to review and issue approval. Additional time will be added for however long it takes to create the supplement itself.

Enlisting Help at the Right Time

For organizations in the midst of a new drug application (NDA) submission, it’s important to understand you will need lifecycle management right after submission. While it may seem you’re almost at the end of a long, arduous process of receiving FDA approval, you’re only at the beginning. Lifecycle management is a condition of approval for the FDA, and your organization must keep the FDA updated on any and all changes made.

To stay on top of this, it’s helpful to partner with an organization. Enlisting seasoned practitioners to help guide your team through the entire lifecycle management will help your staff not only understand the process but ensures regulatory compliance at every stage in your development journey.

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