Microsoft word - richard woodfield - tcmconfap03.doc

Regulation of TCM – synopsis of speech by Richard Woodfield at Chinese
Medicine Legislation Forum on 30 April 2003

• Honour to be invited to speak to this conference.
• I have visited China twice and have had many dealings and discussions with
groups in the UK representative of suppliers and practitioners of TCM • The new Agency is Medicines and Healthcare products Regulatory Agency (MHRA) in place of MCA – but regulatory functions re medicines continues • MHRA responsible for regulation of product rather than practitioner • Will cover briefly: • current regulatory issues and need for regulation • remedy made up by, or at request of the practitioner Regulatory background Objectives • Government’s objective for herbal medicines is to protect public safety and to give continuing access to a wide range of safe, herbal medicines of acceptable quality and with appropriate information about the safe use of the product; this overall statement applies as much to TCM as to other traditions of herbal medicine Current regulation in UK • Where product classified as a medicine, normally requires a product licence or marketing authorisation (based on safety, quality and efficacy); currently no TCMs have achieved a marketing authorisation in this country • In UK there is an exemption (S12) from licensing requirement where product is herbal only; allows unlicensed herbal medicines without claims; • Arrangements do not apply to a herbal medicine which also, for example, contains • Problem with arrangements for unlicensed herbal medicines is lack of effective requirements in relation to safety, quality and patient information • There is particular issue with some TCMs on the UK market made to low quality standards. These pose a threat to public health and to the reputation of responsible practitioners and companies • There have been a number of incidents where TCM products on UK market have been found to contain illegal and undeclared ingredients. Examples include Aristolochia, (sometimes accidentally included instead of other ingredients) fenfluramine, glibenclamide, steroids. • Several years ago the Committee on Safety of Medicines had to advise the public that it could not give the public any assurance as to the safety and quality of TCMs on the market • UK market not unique. These safety/quality issues match international experience and are well recorded in the scientific literature Draft directive on traditional herbal medicinal products • Directive currently under negotiation in Europe; relates to manufactured OTC products suitable for use without intervention of medical practitioner • Evidence of traditional use (in place of efficacy) • Safety mainly also mainly based on long use – but regulatory authority would be
• Quality
• Systematic product information
Issues in negotiations

Will Directive extend to traditional medicines containing non herbal ingredients?
• Latest draft does include provision for this where herbal remedy includes mineral or vitamins where action is ancillary to that of herbal ingredients • Also provision for review of scope of Directive
How much evidence of traditional usage within EU required?
• Earlier draft required minimum 30 years use overall of which minimum 15 • In response to requests for greater flexibility the European Commission’s latest draft proposes that the European Herbals Committee has the power in individual cases to lower the 15 year requirement so that potentially most or even all of the 30 years might be satisfied from outside the EU • The UK and this Agency in particular has been in the lead in pressing for maximum flexibility in relation to non EU traditions. • Many TCMs used in UK for long period already and so for many TCMs EU usage requirement unlikely to be a major hurdle • Rationale for EU requirement – usage outside EU in different populations not necessarily reliable guide – e.g. genetic differences between populations; poorer health/lower life expectancy may mask problems; may not be systematic pharmacovigilance systems; particular issue with chronic conditions where linkage is not immediately apparent Timetable • Not within MHRA’s control but best estimate is that Directive may agreed in c2004; transitional period for existing products until c 2009 • MHRA aim is to work very closely with industry including the Herbal Forum which represents manufacturing trade associations; aim to contain regulatory burden to reasonable minimum. However, important to recognise that putting medicines on the market is a serious business and that people do need to have necessary expertise Regulation where remedies made up by herbalist • This area of regulation is currently under review by Herbal Medicine Regulatory Working Group chaired by Professor Pittilo. Ministers had asked this group for advice. • This area of regulation includes both where a herbalist makes up a remedy and where herbalist commissions a third party to make up a remedy for them • This is an important area of regulation as many TCM remedies are likely to fall into this category (rather than manufactured OTC remedies suitable for use without intervention of medical practitioner) • We will look very carefully at any recommendations that are made and there would be a full public consultation on any proposals for change. Objective as in other areas will be to balance consumer choice and safety Conclusion • Complex and evolving times for regulation of herbal and other traditional • Message we get from many parts of the herbal sector is that the introduction of effective, proportionate regulation could boost public confidence and expand the market; currently responsible operators stand to suffer every time examples of poor quality standards come to light • Agency will be working closely with herbal sector, including representatives of TCM; Note that stated agenda for TCM in China includes modernisation; challenge for TCM sector (in which ever country) is to address systematically the issues of quality. Future growth of TCM in this country could stand or fall by approach to quality.


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