March 2024 Monthly Newsletter

ProductLife Group is pivotal as the regulatory partner within this consortium, providing expert guidance on regulatory compliance and audit preparation. PLG’s involvement in the consortium deepens our regulatory expertise and contributes to accelerating patient access to innovative health technologies. By bridging the gap between cutting-edge research and regulatory approval, PLG is poised to revolutionize the landscape of home sleep testing, ultimately enhancing patient outcomes and advancing healthcare innovation. Thanks to this EIT Health flagships program, APNEAL, which introduced groundbreaking progress in sleep apnea testing, gains financial backing and operational support through a network of key players in the European sleep apnea ecosystem.

PLG announces the acquisition of HCS, a leading Moroccan consultancy whose reach spans across more than 30 different African countries. With this alliance, PLG reinforces its ability to support client regulatory and compliance needs globally. As Abderrahim Bouabidi Ph.D, Ph.D., Founder & Managing Director​ of HCS, reminded: “Joining PLG offers a lot of possibilities to our consultants. They may work on larger global scale projects, with new clients worldwide, and improve their competencies thanks to the diversity of their new colleagues and the HR global support.”

PLG role is to support elaborating and assessing the regulatory strategy for this AI-enabled software-as-a-medical device and to build the clinical evaluation report as a critical deliverable to demonstrate there is sufficient clinical evidence to verify the safety and performance of the device.
Thanks to its R&I Center managed by Gabrièle Breda, our Research and Innovation Director, PLG has taken a leadership position in driving innovation along the roads of Regulatory Science, A.I., and healthcare solutions.

Health Canada announced modifications to the List of Permitted Supplemental Ingredients and added Green Tea Extract (EGCG and catechins) for use in supplemented foods (NOM/ADM SI-007). Specific conditions, cautionary statements on labels, and dosage limits were introduced, with a maximum single dose of 100 mg EGCG and 200 mg total catechins. The daily limits are set at 300 mg for EGCG and 600 mg for catechins. In Europe, a similar regulation (Annex III of the Regulation (EC) No 1925/2006) outlines requirements (use and label warnings) for green tea extracts, limiting daily EGCG intake to less than 800 mg. The regulations came into force on January 11, 2024, with a transition period until December 31, 2025, allowing existing products to comply with the updated rules for continued market access.

On February 9th, 2025, Italy will adhere to the European Medicines Anti-Counterfeiting Directive (EU FMD), mandating a unique identification of drug packages and implementing tamper-evident measures to ensure authenticity from manufacturing to dispensing to the final patient. The Italian regulatory system will have to transpose the directive and potentially expand its scope — the complete replacement of the Tamper Evident is under discussion. Serialization projects are intricate and involve various functions within Marketing Authorization Holder (MAH) companies and their business partners. The EU FMD Directive assigns specific responsibilities to wholesalers within the territory.To meet this challenge, it is essential to be prepared. LifeBee, ProductLife Group Digital expertise center, supports companies in fully understanding this legislation’s implications and ensuring full project compliance.

Natashia De Casamassimi, PLG’s Head of Regulatory Affairs, introduced the benefits of strategic outsourcing in facing regulatory challenges on the 12th. Gabrièle Breda, PLG’s R&I Director, with a panel of seasoned experts, brought light on opportunities, challenges, and benefits of innovation in labeling on the 13th.

Not only the number of attendees but also the quality of engagement was remarkable. Thanks to Abbvie, MSD of UCB, for being there.

ProductLife Group, through Intexo Società Benefit (A ProductLife Group Company), is now a member of Club Santé Italie. PLG’s intentions with this partnership is to grow our connectivity within the Italian market and to bring agile and innovative solutions to clients entering said market as well as those clients who want to expand their reach out of Italy into the global sphere. PLG’s mission is to improve human health through regulatory compliance services for safe and effective medical solutions, ensuring continuous growth and innovation.

ProductLife Group is committed to developing our client’s skills and competencies to meet their growing business requirements and fulfill their company’s goals. In keeping with this commitment, we are pleased to announce that we are now an Enterprise Member of the Regulatory Affairs Professionals Society (RAPS). RAPS is the largest global organization for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products.