Question
What are the principal quality and efficacy tests which must be met by manufacturers submitting products for registration under the traditional herbal medicinal products directive (2004/24/EC); and, inthe case of each such test, what are the costs of compliance assumed in the regulatory impact assessment produced for the directive; and
Answer
It is a commercial decision for individual companies whether to apply for a traditional herbal registration (THR) under the provisions flowing from directive 2004/24/EC. The Medicines and Healthcare products Regulatory Agency (MHRA) is not in a position to estimate how many applications will be submitted. So far the MHRA has received 38 THR applications, of which 33 are for products containing a single active ingredient and five are for combination products. The MHRA expects that a high proportion of early applications will be for relatively simple products while companies become accustomed to meeting the regulatory requirements of the scheme. There is normally no requirement for applicants to submit information on the efficacy of the product under the THR scheme. The quality requirements for herbal medicinal products and traditional herbal medicinal products are set out in detailed guidance documents following consultation with industry. The European Pharmacopoeia also sets out legally binding standards for herbal ingredients as well as excipients used in herbal medicinal products. The purpose of the quality tests is to ensure that the herbal medicinal product is safe for use and has a reproducible quality over its proposed shelf-life. Tests are required to ensure that the correct plant materials are used, free from potentially hazardous contaminants such as pesticide residues, fumigant residues, heavy metals/other toxic elements, mycotoxins, bacteria/fungi. Where herbal extracts are employed tests are required on all materials used, including solvents and reagents used for extraction, to ensure that they are as intended and of acceptable quality. The herbal extract undergoes tests to ensure it is of reproducible quality and that it is free from hazardous levels of, for example, residual solvents, micro-organisms or potential contaminants from the starting plant materials. The finished dosage form is tested to ensure that it contains the declared amount of herbal ingredients and that it will remain of suitable quality throughout the proposed shelf-life. In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme could be several tens of thousand pounds but that the figure would vary widely according to specific circumstances, not least depending on whether companies already had systematic quality control systems in place. This assessment has not changed. European and United Kingdom medicines legislation requires manufacturers and/or importers of registered traditional herbal medicines for human use to hold a manufacturer's licence. It is a condition of such a licence that the holder must have a qualified person (QP). The QP must either meet existing specific educational and vocational requirements or attain status through transitional arrangements. The QP has a personal responsibility for certifying that each batch of registered traditional herbal medicine has undergone the appropriate tests, complies with its registered specification and has been manufactured in accordance with good manufacturing practice. The purpose of these requirements is to ensure that a safe quality traditional herbal medicine is placed on the market. The directive on traditional herbal medicinal products requires manufacturers of registered herbal medicines to be authorised by the national competent authority. In the UK, the MHRA authorises and inspects manufacturers. The inspection fee is currently £1,496 for a full day and £920 for half a day. Manufacturers must meet certain conditions and employ a QP in order to be authorised. A number of manufacturers were already authorised to manufacture herbal medicines before the directive came into force. Since the implementation of the directive all of the small number of manufacturers who have applied specifically to manufacture registered herbal medicines have been authorised. The European Commission launched a public consultation in May 2007 on the review of the operation of directive 2004/24/EC. The consultation included data up to March 2007. It is the European Commission's responsibility to report on the findings of that review and, pending that outcome, we have no present plans to press for an early second review.