What is the Emerging Drug Safety Technology Program (EDSTP) And its Eligibility Criteria?

Ensuring drug safety is vital, and the Emerging Drug Safety Technology Program (EDSTP) is leading the way.

In the past, monitoring drug safety was tough. It involved a lot of paperwork and managing vast amounts of data on adverse drug reactions.

Now, new technologies like artificial intelligence are making a big difference. These advanced tools can automate tasks such as data intake, entry, and processing. This reduces administrative work and costs while making it easier to track drug safety.

With AI, we can handle and analyze much larger and more varied sets of data.

Introduction to EDSTP

The Emerging Drug Safety Technology Program (EDSTP) is an innovative initiative focused on integrating artificial intelligence (AI) and other emerging technologies into pharmacovigilance (PV). PV emphasizes keeping an eye on drug safety after they hit the market. 

Started by the Center for Drug Evaluation and Research (CDER), this program strives to make sure drugs stay safe throughout their lifecycle.

The EDSTP has three primary goals:

• It acts as the go-to point for discussion between the pharmaceutical industry and CDER regarding the use of AI and emerging technologies in PV.
• It facilitates the transfer and management of knowledge within the FDA.
• It helps gain a deep understanding of how AI and emerging technologies are applied in PV.

To reach these goals, the CDER has put together the Emerging Drug Safety Technology Meeting (EDSTM) program.

These meetings pave the way for open conversations, helping the FDA get a better grasp of how AI tools are being used in pharmacovigilance (PV). 

Who Can Request EDSTMs: Eligibility and Beyond 

To participate in the EDSTM program, applicants and other relevant parties must meet specific eligibility criteria:

1. Approved Applications Regulated by CDER

If your business holds an approved application regulated by the CDER, you are eligible to request an Emerging Drug Safety Technology Meeting (EDSTM). 

This covers -

Simply put, if your business has received approval for any of these types of drug applications, you can participate in an EDSTM.

2. Relevant Parties Supporting PV Activities

Entities that support the industry's PV activities can also apply. This includes, but is not limited to, academia, Contract Research Organizations (CROs), pharmacovigilance vendors, and software developers. 

These organizations are integral in developing or leveraging AI and other technologies to meet post-marketing reporting requirements.

3. Scope of Use

Eligible technologies should be geared toward post-market PV activities. While some technologies may be useful for both pre- and post-market PV, the EDSTM program explicitly focuses on post-marketing surveillance. 

The regulatory requirements that these technologies aim to comply with include 21 CFR 314.80, 314.98, and 600.80, which outline the standards for postmarketing reporting.

4. Partnership Opportunities

The program allows not only individual applicants to request meetings but also facilitates joint applications. 

For example, an applicant and their PV vendor could jointly request an EDSTM. This cooperative approach could lead to more comprehensive and insightful discussions.

Stay at Par With the Safety Standards

The EDSTM program offers great opportunities to integrate the latest technologies into post-market drug safety monitoring, making the medicines safe for everyone.

Whether you hold an approved application, or if you're a relevant party involved in pharmacovigilance activities, participating in the EDSTM program can help you leverage technology for better public health outcomes.

FAQs

Q. What is the Emerging Drug Safety Technology Program (EDSTP)?

The EDSTP is an initiative focused on adopting innovative tools and ways to make sure drugs are safe. It aims at improving how we monitor medications in real-time to ensure drug safety.

Q. How do we apply for the EDSTP?

Applying for the EDSTP is pretty straightforward. You need to fill out an application on the program’s website. Provide accurate details about your current projects, your tech capabilities, and how you plan to help improve drug safety. Just make sure to go through the eligibility criteria and application requirements carefully before hitting submit.

Article Author

Steve Thomas

Operations and Compliance

Working in Operations and Compliance at Drugzone Pharmaceuticals Inc. ,I manage Regulatory Strategy, Operations Management, Business Strategy, and many more. I also have experience in Project management, budgeting, and team leadership.