EU Regulation of Herbal Medicinal Products
Posted: Wednesday, 29th, 2015 | Filed under: Medical Regulatory Affairs, EU medical compliance, Global Healthcare Industry, Healthcare regulatory affairs, medical regulatory, regulatory consulting | author: David Johnston
Protecting public health whilst maintaining the free movement of herbal medicinal products
The 2004/24/EC Directive’s aim is to protect public health while at the same time maintain the free movement of herbal medicinal products within the Community by streamlining the registration process. While most individual herbal medicinal products have continued to be licensed nationally by Member States, the process for licensing has been increasingly harmonised across the European Union.
Under the guidance, all manufacturers of herbal products were instructed to put in place the same quality controls as pharmaceutical products and ensure they are manufactured to Pharma GMP. It also placed restrictions on the type and number of health claims to only those that have sufficient scientific evidence or long standing history of traditional use. The directive also required the creation of a Herbal registration scheme within each EU member state to facilitate free trade between EU countries.
When the directive came into force the manufacturers had until April 2011 to comply with the new guidelines. Any manufacturer who did not meet the new quality standards were forced to remove their product from the market until the standards could be met. It is important to note that herbal remedies custom-made for a patient by a registered herbalist are exempt from the directive.
Market access for herbal medicinal products in the European Union
Herbal medicines are subject to the same general requirements as conventional medicines and need to be registered with a Member State’s competent authority in order to be marketed in the European Union. The applicant needs to submit an application containing all necessary information on the product itself as well as data on quality, safety and efficacy.
Formerly medicinal products containing herbal substances/preparations fell within one of two categories in order to reach the market: either licensed under “full application” (article 8(3)) or under the “well-established” medicinal use provisions (article 10.1(a)). Both these routes have no restrictions regarding the strength, posology or route of administration so long the data is available to support the claim (sourced either from trials or scientific literature).
Under the new directive an applicant can now register their herbal medicine a third way without the need for expensive clinical trials and tests:
- Registered under a simplified Traditional Herbal Medicines Product (THMP) Scheme (“Traditional Use” or Article 16a)
- Intended for herbal medicinal products with a long tradition
- No requirement for clinical trials and tests to prove the products safety and efficacy. Instead need to show sufficient evidence that is has been used throughout a period of at least 30 years (15 of these must have been within the EU)
- Limited route of administration, strength and posology (based on traditional use)
Regardless of the regulatory pathway chosen to access the market, the quality of the herbal medicinal product must always be demonstrated. I.e. manufactured to GMP, conforms to European Pharmacopoeia standards with regard to residual solvent levels, microbial, pesticide and heavy metal limits and a suitable stability profile to support the intended shelf life (two year stability study according to ICH guidelines).