Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Tranditional Herbal Medicinal Products Used in Children

Drug Regulators, EMA, Publish Reflection Paper on Ethanol Content in Herbal Medicinal Products and Traditional Herbal Medicinal Products Used in Children

Full Text Here

Herbal medicinal products may contain significant levels of ethanol arising from its use as an extraction solvent in liquid extracts and tinctures or when added as a diluent to liquid herbal preparations. The use of ethanol is necessary for extraction of some constituents that are important for efficacy. Ethanol is metabolically active, therefore formulations without ethanol or with the lowest achievable level should be selected to avoid systemic exposure when the target population is children.

The scope of this paper is to reflect the need for safety limits for ethanol exposure by oral herbal medicinal products intended for the paediatric population. Establishing these limits is viewed as necessary to protect health and to allow safe free movement of goods within the EU. In addition, this will ensure a harmonised approach in assessment work among Member States as well as in the establishment by the HMPC of Community herbal monographs and of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (respectively Article 16h (2,) and Article 16f (3) of Directive 2001/83/EC as amended).

For Assistance with Regulatory Planning and Execution of Clinical Trials Click Here

Damien Bové is the drug development and regulatory consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Fill Out the Short Form Below…

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”