Bringing new drugs and therapeutics to a global market requires extensive planning. Requirements for soliciting early-stage regulatory feedback differ across geographies, so it might be tempting to file new drug submissions separately. However, planning a comprehensive global IND submission can save developers time and money.
The importance of a global program
A global IND program can eliminate the need for duplicate studies, enabling a faster expansion into foreign markets. To secure the best possible outcome, developers should file a global IND submission at the beginning of the planning phase, and with foresight, they can ensure all studies adhere to regulations across the world.
The major differences between regulatory requirements can be categorized into three areas:
- Study conduct (including personnel roles, documentation, and changes in the scope of work)
- Reporting expectations
- Archiving procedures
It’s all in the details
Although many study designs are similar, differences in fundamental terminology, documentation requirements, and participant roles exist across regulatory agencies. For instance, some require unique identification for each study and require them to be traceable to their origin.
Other regulators require adequate labeling with specific information. While this may seem minor, addressing these nuances is crucial to ensure compliance and avoid significant delays. Identification of key personnel, including the testing facility, TFM, study director, and principal investigators, is vital across regulatory bodies, albeit with variations in authority and signature requirements on final documents.
Study design nuances
Study designs also vary between regulators. These variations include:
- Differing requirements
Differences in test system requirements between regulatory bodies highlight the nuances that drug developers should look for. While essential details like identifying test, control, and reference articles are similar across agencies, there can be slight variations. Such variations directly impact study protocol clarity, particularly concerning intended countries for IND submission. Understanding shared elements and discrepancies is crucial for designing cohesive studies.
- Reviewing reporting expectations
Reporting standards differ across regulatory agencies, and the scope, content, and context of IND submissions can contain the tiniest differences. Drug developers must meticulously review each agency’s comprehensive guidelines and monitor regulatory updates.
- Archiving study data
A global mindset in the first phases of development will ensure that developers are archiving appropriately throughout the entire process. Considering global perspectives during development ensures compliance with archival requirements across regulatory agencies.
Navigating the complexity
Navigating regulatory requirements can be daunting for drug developers, but partnering with a laboratory testing partner can streamline the process and ensure nuances are addressed, additional costs minimized, and timeline requirements met. Lab partner expertise varies greatly, so developers should ask potential partners about their experience in global study preparation, including inspection support, translation services, and regulatory strategy. A worthy lab partner will understand and address agency differences and tailor applications accordingly.
Developers can save time and money when filing IND packages to multiple agencies by considering the regulatory variations from start to finish. The laboratory’s approach to study design can significantly impact results, so selecting the right partner is critical.
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