GMP for Traditional Herbal Medicinal Products

A vast majority of herbal medicines are currently on sale in the UK under Section 12 of the 1968 Medicines Act as 'medicines exempt from licensing'. October 2005 however, marked the introduction of a new scheme, the Traditional Herbal Medicines Registration Scheme (THMRS), which is aimed to help protect public health by requiring specific standards of safety and quality for traditional herbal medicines. This will also facilitate the free movement of traditional herbal medicinal products.

Under this new scheme, all manufactured herbal medicines placed on the UK market are required to have either a Traditional Herbal Registration (THR) or a Marketing Authorisation (MA). The only exception being those products placed legally on the market under the 1968 Medicines Act by 30 April 2004 which can continue to be marketed as unlicensed herbal remedies until 30 April 2011.
The simplified procedure allows the registration of THMPs without requiring detailed documentation on tests and trials on safety and efficacy, provided that there is sufficient evidence of the medicinal use of the product throughout a period of at least 30 years, including at least 15 years in the EU.

Traditional herbal medicinal products must now also fulfil the same manufacturing requirements as applications for a marketing authorisation, therefore important quality aspects such as stability and method validation data must also be addressed.

The product must first be manufactured at pilot scale, within a GMP approved manufacturing facility using a validated process. Three product batches are required for stability testing carried out under ICH conditions of differing temperature and humidity and should be performed on the product packaged in the exact containers proposed for marketing. A summary of the stability studies undertaken, including storage conditions and the batch analytical data is required for submission. Analytical data is gathered at different time points throughout the study using validated methods developed specifically for the finished product. Validation documentation is required to prove that the method used is fit for purpose and data relating to method sensitivity, accuracy, range of analysis and precision must be collected and submitted.

Broughton Laboratories can now offer pre-registration support including:

• Development of analytical methods for herbal medicines
• Method validation to full ICH requirements
• Stability storage and testing to full ICH requirements