Phytopharmaceuticals have been a testament to the natural healing power of the plant world since time immemorial. Their use enables a range of health problems to be addressed in a holistic and natural way.
The continued importance of herbal medicinal products is reflected in the lively participation of pharmaceutical industry representatives at the annual Alphatopics Phytopharmaceutical Symposium. From September 26 to 28, 2023, the established industry meeting took place for the 12th time in the usual manner at the Universitätsclub in Bonn.
The focus this year was primarily on similarities and differences between various product groups with herbal ingredients.
During the symposium, experts from authorities and various companies, including specialists from TentaConsult Pharma & Med GmbH, shared their extensive expertise and presented innovative strategies in this dynamic field. In particular, the consideration of substance-based medical devices, with herbal ingredients in view of the requirements of the EU Medical Device Regulation (MDR) extended the program as a pre-symposium.
Navigating regulatory waters!
The discussion focused on both the demarcation of medical devices and medicinal products - a critical issue whose importance is increasing due to the reclassification of many medical devices according to the MDR - and the need to implement and continuously maintain a quality management system (QMS) according to DIN EN ISO 13485.
At the same time, the importance of generating and evaluating robust clinical data was highlighted, which is essential for demonstrating the performance, safety, and benefit of the product relative to the risk. In addition, it was discussed how a successful transition from herbal medicinal products to drug status can be realized and the challenges that need to be overcome.
Transition to traditional herbal medicines: A Chance for Herbal Medical Devices!
Furthermore, the regulatory opportunity for a switch of substance-based medical devices with herbal ingredients to traditional herbal medicinal products ("THMPs) was discussed. Based on the evidence of many years of medicinal use (at least 30 years, of which at least 15 years in the EU), an application for registration as a THMP can be submitted for these products. However, this route will only be possible if the requirements of the pharmaceutical law are implemented, for example, if in the end the holder of the registration is also the pharmaceutical entrepreneur and the product is produced under GMP.
"The collaboration with Alphatopics at this annual symposium gave us a unique platform for discussions on current topics in the field of herbal medicinal products and substance-based medical devices and enabled a valuable exchange of knowledge regarding regulatory challenges," emphasized Anja Heinrich, Head of Medical Device Services at TentaConsult.
For information or individual consulting on the above topics as well as further services in the areas of Regulatory Affairs, Quality Management, GxP, Clinical & Medical Affairs, Vigilance & Post-Market-Surveillance, TentaConsult Pharma & Med GmbH is at your disposal.
Address Martinsried:
TentaConsult Pharma & Med GmbH
Fraunhoferstr. 9
82152 Planegg/Martinsried, Germany
Address Münster:
TentaConsult Pharma & Med GmbH
Wienburgstr. 207
48159 Münster, Germany
Tel:+49 251 928 715 60
info@tentaconsult.de
About TentaConsult Pharma&Med GmbH:
The TentaConsult Pharma & Med GmbH, with seat in Mnster and Munich, is a consulting firm for the Pharma and medicine product range. Under the umbrella of the Tentamus Group, TentaConsult focuses on comprehensive services and consulting in almost all aspects of Regulatory Affairs, Quality Management, Clinical & Medical Affairs, Vigilance & Surveillance - both for pharmaceuticals and medical devices.
The company supports its clients in meeting the requirements necessary to bring drugs, medical devices, nutraceuticals and cosmeceuticals to market and to maintain their marketability, not only in Germany, but also in Europe and worldwide. In doing so, TentaConsult's consultants place great emphasis on the feasibility and cost-effectiveness of their clients' projects.
The continued importance of herbal medicinal products is reflected in the lively participation of pharmaceutical industry representatives at the annual Alphatopics Phytopharmaceutical Symposium. From September 26 to 28, 2023, the established industry meeting took place for the 12th time in the usual manner at the Universitätsclub in Bonn.
The focus this year was primarily on similarities and differences between various product groups with herbal ingredients.
During the symposium, experts from authorities and various companies, including specialists from TentaConsult Pharma & Med GmbH, shared their extensive expertise and presented innovative strategies in this dynamic field. In particular, the consideration of substance-based medical devices, with herbal ingredients in view of the requirements of the EU Medical Device Regulation (MDR) extended the program as a pre-symposium.
Navigating regulatory waters!
The discussion focused on both the demarcation of medical devices and medicinal products - a critical issue whose importance is increasing due to the reclassification of many medical devices according to the MDR - and the need to implement and continuously maintain a quality management system (QMS) according to DIN EN ISO 13485.
At the same time, the importance of generating and evaluating robust clinical data was highlighted, which is essential for demonstrating the performance, safety, and benefit of the product relative to the risk. In addition, it was discussed how a successful transition from herbal medicinal products to drug status can be realized and the challenges that need to be overcome.
Transition to traditional herbal medicines: A Chance for Herbal Medical Devices!
Furthermore, the regulatory opportunity for a switch of substance-based medical devices with herbal ingredients to traditional herbal medicinal products ("THMPs) was discussed. Based on the evidence of many years of medicinal use (at least 30 years, of which at least 15 years in the EU), an application for registration as a THMP can be submitted for these products. However, this route will only be possible if the requirements of the pharmaceutical law are implemented, for example, if in the end the holder of the registration is also the pharmaceutical entrepreneur and the product is produced under GMP.
"The collaboration with Alphatopics at this annual symposium gave us a unique platform for discussions on current topics in the field of herbal medicinal products and substance-based medical devices and enabled a valuable exchange of knowledge regarding regulatory challenges," emphasized Anja Heinrich, Head of Medical Device Services at TentaConsult.
For information or individual consulting on the above topics as well as further services in the areas of Regulatory Affairs, Quality Management, GxP, Clinical & Medical Affairs, Vigilance & Post-Market-Surveillance, TentaConsult Pharma & Med GmbH is at your disposal.
Address Martinsried:
TentaConsult Pharma & Med GmbH
Fraunhoferstr. 9
82152 Planegg/Martinsried, Germany
Address Münster:
TentaConsult Pharma & Med GmbH
Wienburgstr. 207
48159 Münster, Germany
Tel:+49 251 928 715 60
info@tentaconsult.de
About TentaConsult Pharma&Med GmbH:
The TentaConsult Pharma & Med GmbH, with seat in Mnster and Munich, is a consulting firm for the Pharma and medicine product range. Under the umbrella of the Tentamus Group, TentaConsult focuses on comprehensive services and consulting in almost all aspects of Regulatory Affairs, Quality Management, Clinical & Medical Affairs, Vigilance & Surveillance - both for pharmaceuticals and medical devices.
The company supports its clients in meeting the requirements necessary to bring drugs, medical devices, nutraceuticals and cosmeceuticals to market and to maintain their marketability, not only in Germany, but also in Europe and worldwide. In doing so, TentaConsult's consultants place great emphasis on the feasibility and cost-effectiveness of their clients' projects.
