Regulations worldwide

[Guest guest]

Hello CH Academy:

The issue of herbal regulation is not new in Europe and Canada or in many other

countries. Following are several instructive links provided to me by Bill Egloff

of Crane Herbs and reproduced here with his permission. Bill will be speaking on

this topic at the Alliance conference in Safety Harbor, Florida on Saturday

morning, May 3. Cindy Beehner, a regulatory consultant to the supplement

industry, will also be speaking that morning on how FDA regulations impact us as

compounding pharmacies. My hope is that by providing this information to

practitioners we can help each other find workable solutions to comply with

regulations already in effect, and have a greater number of practitioners

involved in discussions about potential new regulations.

Best, Mercy

 

This from Bill Egloff:

 

1. According to the new European Directive, any herbal medicinal product

(or formula), including TCMs, would have to be on the market

(internationally) for at least 30 years with at least 15 years

availability in Europe (although I've heard that there may be an

amendment changing this to 10 years; see story at:

http://www.npicenter.com NBPrintDocuments.asp?DocumentID=3520). Certain

associations in EU countries like the UK, where TCM and Ayurveda are

recognized and have special status, may be participating in the creation

of " positive lists " of medicinal herbs and products that have been in use

in their country for at least 15 years, particularly Chinese, Indian and

South American herbs and medicinal herbal products. Associations or

groups that may be involved in this activity include the European Herbal

Practitioners Association and/or its working group (established with the

UK Department of Health), the Herbal Medicines Regulatory Working Group

(HMRWG). Also, the Working Party on Herbal Medicinal Products (HMPWP) of

the European Agency for the Evaluation of Medicinal Products (EMEA) plans

to give technical advice in the next steps of the preparation of the EU

Directive on THM Products and to support its implementation (see page

four of the following document:

http://www.emea.eu.int/pdfs/human/hmpwp/654102en.pdf).

See also the following document from Michael McIntyre, Chairman of the

European Herbal Practitioners Association (EHPA):

http://www.users.globalnet.co.uk/~ehpa/briefing_update_270103.htm

 

For numerous other documents on the Directive, posted by the EHPA, see:

http://www.users.globalnet.co.uk/~ehpa/

Also, for a letter of support for the Directive, dated 17 January 2003,

from the National Institute of Medicinal Herbalists (NIMH) see:

http://www.nimh.org.uk/DTHMP_1.htm

 

2. Regarding Custom Formulas and cGMP's? If they are closely comparable

to an approved traditional formula, there may be a way for expedited

approval, as a modification of an approved THM. With regard to cGMPs, in

most EU countries medicinal herbal products have already been regulated

as drugs, and therefore, they are already required to be manufactured

according to drug GMPs as opposed to food GMPs. See the following

document for information on quality requirements under the Directive:

Medicines Control Agency Symposium ; Quality and safety at heart of new

herbal directive - Available at:

http://www.pharmj.com/pdf/forum/pj_20030208_mca.pdf

 

3. Regarding NEW formulas, at present, in most EU countries, herbal

medicinal products are already required to obtain pre-marketing

authorization as a drug product. This is nothing new. In countries like

Germany, Switzerland, and Austria, even simple medicinal herbal teas have

always had to go through drug registration and approval. The

manufacturers have to submit safety and efficacy dossiers and the

products have to be manufactured under drug GMPs.

 

4. This directive will probably become a law in 2004 followed by a

five-year transitional period (yes, ostensibly, 2009).

 

5. Regarding " caution " or " toxic " herbs, each EU country already has a

process, within the existing requirements for drug pre-marketing

authorization. Safety and efficacy dossiers must be submitted by the

company before obtaining a product license number, etc...

 

6. Differences between an individual country's determination and EU :

individual country's determinations will need to be harmonized into a

single EU regulation. Each country will likely submit its own " positive

lists " for inclusion in the master EU list of approved traditional herbal

medicines.

 

7. EU countries demand licensure today. Many European countries already

regulate Traditional Herbal Medicines as drug products (e.g. Germany

Austria, Switzerland, Poland, France, Sweden), thus requiring

pre-marketing authorization and annual drug licensing re-registrations,

etc... The UK is somewhat different, however, in that the Medicines

Control Agency (MCA) has a document entitled " Consolidated List of

General Sale List Substances " , which includes 'General Sale List'

medicinal herbs that are approved for use, albeit in fully licensed

medicinal herbal products. A very useful WHO document that explains the

present regulatory situation of herbal medicines in each country is

available at:

http://www.who.int/medicines/library/trm/who-trm-98-1/who-trm-98-1.pdf

 

8. Regarding the new Canadian regulations for over-the-counter (OTC)

Natural Health Products (NHPs), which includes Traditional Herbal

Medicines (all systems), Traditional s, Traditional

Indian Systems of Medicine (Ayurvedic, Siddha, Unani), Homoeopathic

Medicines, Vitamins & Minerals, and North American Aboriginal Medicines,

etc... see:

http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/regs_cg1_new.pdf

 

For other information from the Canadian Natural Health Productsate, see: http://www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/index_e.html

 

Personally, I view the new Canadian regs for NHPs to be quite reasonable

and believe that they should become a model for the US FDA to consider

for the future of so-called herbal dietary supplements. Medicinal herbal

products, in my view, are not dietary supplements and eventually should

be regulated as, for the most part, OTC Traditional Herbal Medicines (or

Natural Health Products), as is the case in Canada, Australia & New

Zealand, and the EU. The US regulatory system for herbal medicinal

products is certainly an anomoly in the world.

 

Legislation Forum

29th April 2003

Venue: The Royal College of Physicians (London)

Theme: To discuss the urgent regulatory issues facing in

the UK and in Europe, and to formulate a suitable legal position for

to benefit the western healthcare system.

Organised by:

Association of Traditional (ATCM)

British Society of (BSCM)

Chinese Medical Institute and Register (CMIR)

General Council of Traditional (GCTCM)

Sponsors:

State Administration of (SATCM)

World Health Organisation (WHO)

Pan European Federation of TCM Societies (PEFOTS)

Information Contact: Preparation Committee Chairman Prof. Man Fong Mei,

CMIR, 101-105 Camden High Street, London NW1 7JN, UK. Tel: +44(0) 207 388

6704 Fax: +44 (0) 207 383 3988

 

 

These are large questions and deserving of much more in-depth discussion

and consideration, but, time is limited. Hopefully, some of the links

I've provided will lead you in directions that provide more useful

information on the topic.

 

Be well,

Bill Egloff