Quality Resolutions

Quality Resolutions

Blog 1216
Blog 1216

There are no holidays or time off when it comes to complying with regulations. Companies always need to be ready to meet the latest standards. With that in mind, new FDA programs are sure to keep pharmaceutical companies of all sizes busy in the year ahead. Here’s how to get through.

Developing a global CMC regulatory strategy document should be on top of a company’s “to-do list” in 2022. This document provides a blueprint for a regulatory strategy to achieve a company’s objectives in developing and ultimately supporting a drug. The strategy document should include information such as:

  • Product’s indication, intended use, and target population
  • Partners involved in the product (e.g., research or manufacturer organizations, consultants, submission outsourcing partners)
  • Product registration strategy
  • Order of application filings (e.g., which countries and when)
  • Country specific requirements (e.g., local requirements)
  • Submission timelines
  • Short- and long-term regulatory objectives
  • Manufacturing strategy

Given their focus on discovering and rapidly building scientific evidence to support the safety and efficacy of their compounds, emerging pharma companies often direct their limited resources to near-term activities. In doing so, they are often unaware of or undervalue the importance of getting early CMC regulatory guidance on long-range development strategies.

In early development, emerging companies often view regulatory affairs as a function that is primarily necessary to ensure compliance. They recognize the need to manage operational activities such as preparing, submitting, and maintaining an IND, submitting information amendments, and coordinating other routine communications with the FDA. However, this approach potentially neglects a greater value-added contribution that these experts can provide: regulatory strategy. Unfortunately, there are no guidelines or regulations that explain how a CMC regulatory strategy should be compiled. However, several industry organizations have resources and conferences that outline what should be included for pharmaceuticals and biologics in a regulatory strategy.

While the creation of a solid CMC regulatory strategy is a critical enabling factor in the efficient development of a product for both emerging and established companies, there is particular importance for emerging companies since they typically have fewer available resources than larger companies. For smaller organizations, an external regulatory strategist can serve as a bridge between scientific and commercial disciplines, integrating their respective needs, forming a cohesive internal strategy, and developing an external communication approach for the health authorities. In this way, the strategist can provide efficiencies to development teams, informing the sponsor of requirements and options while outlining a pathway and defining the hurdles to registration.

As pointed out, the key to gaining the greatest efficiencies, however, is to launch the development of the regulatory strategy early in development, ideally before starting clinical trials. In that way, the regulatory expert is an integral part of the team for all the subsequent critical steps, including implementation and negotiation with health authorities.

The year 2022 will be challenging for pharmaceutical companies, given the ever-evolving requirements of the FDA. Although this fact should not come as a surprise to anyone in the industry, companies still need to be prepared and be able to move quickly so as not to compromise their businesses.