On January 9, 2025, the 2025 Global NGP Compliance Development Symposium, organized by 2Firsts, concluded successfully in Shenzhen. The seminar aimed to promote global compliance development and advocate for companies to actively embrace the new era of compliance. More than 10 renowned compliance industry experts and representatives from China and around the world delivered keynote speeches through a combination of online and offline formats, attracting nearly 200 participants from various sectors, including international tobacco companies, top Chinese e-cigarette companies, leading supply chain companies, and researchers. The conference was organized by the global leading NGP industry media —2Firsts.
Dr. Jessica Zdinak, Chief Research Officer of Applied Research and Analysis Company LLC (ARAC), attended the seminar and delivered an online presentation on the topic "Challenges and Consideration Factors for Enterprises Applying for PMTA in 2025."
In her speech, Dr. Jessica Zdinak delved into the development trajectory and future trends of the American tobacco products market, particularly emphasizing the FDA's core regulation of "protecting public health." She reviewed key turning points in the market from the dominance of combustible cigarettes to the enactment of the Tobacco Control Act, the implementation of the PMTA process, and pointed out that many manufacturers often encounter the dilemma of long delays and slow review progress after submitting PMTA scientific research and applications, resulting in application periods ranging from five to seven years.
Dr. Jessica Zdinak also analyzed the shortcomings of the Center for Tobacco Products (CTP), a newly established federal agency, in terms of infrastructure development and experience accumulation from 2022 to 2024, as well as the chaotic review situation that arose after receiving a large number of applications. Looking ahead to 2025, under the leadership of a Republican-dominated administration, she expects the FDA to significantly improve the efficiency of reviewing PMTA applications and increase efforts to crack down on overseas products entering the market without authorization.
At the 2025 Global New Year Symposium on the Development of New Tobacco Regulations, Dr. Jessica Zdinak's professional speech received widespread praise and enthusiastic response from attendees. After the speech, many participants expressed that the information helped them gain a deeper understanding of the regulatory dynamics of the American tobacco product market, the complex process of PMTA applications, and future development trends, providing guidance for strategic planning and compliance layout for businesses. At the same time, attendees also expressed sincere gratitude to the organizers of the event. They believed that the organizers had created a high-quality compliance communication platform, greatly promoting communication and interaction among various parties in the industry, and effectively driving the industry's stable development on the compliance path.
As a leading media and think tank in the field of Next Generation Products (NGP) globally, 2Firsts actively maintains close communication with various testing and regulatory agencies, building a strong bridge for industry resource sharing and information exchange. In the future, 2Firsts will continue to integrate resources and consolidate wisdom, working hand in hand with industry partners to promote the high-quality development of the global NGP industry, and contribute lasting strength to the industry's innovation breakthroughs and compliant advancement.
Regarding ARAC
Applied Research and Analysis Company (ARAC) is a leading U.S. based behavioral science research firm that designs, executes, and presents scientifically-sound, yet customizable studies to support manufacturers, regulatory agencies, and industry consultants. Their expertise includes consumer-focused research services in product development and innovation and regulatory science supporting marketing authorization applications, with SUCCESS in U.S. product authorizations and applications.
ARAC specializes in MODULE 5 & 6 studies including: label/claim development and comprehension, human factors/usability testing, and clinical/behavioral studies, such as randomized experimental longitudinal, actual use, TPPI, and post-market surveillance systems.
“Most Outstanding Service to Industry” 2024 Golden Leaf award-winning fully staffed IN-HOUSE psychologists, behavioral scientists, statisticians, survey methodologist, and medical monitoring offering tailored research solutions with unparalleled integrity and an exceptional client experience.
For more infornation, click HERE to watch the presentation replay.
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