Health Canada regulations

[Guest guest]

Health Canada is working on regulations for " natural health products " ,

that include Chinese herbal meds. Below are the main topics. For more

info, you can go to Health Canada website: http://www.hc-sc.gc.ca.

 

Comments?

 

 

rene

 

======================================================================

Overview of the proposed regulatory framework:

What does it mean?

 

 

The following is an overview of the proposed

Regulations being pre-published in the Canada Gazette, Part I,

accompanied by an interpretation for each section.

 

Definitions

 

The proposed Regulations provide definitions of " natural health product "

and other terms such as " manufacturer " , " adverse reaction " and

" brand name " , which are key to the functioning of the proposed framework.

 

The definition of a natural health product

helps to differentiate it from a pharmaceutical or a food so that

the Regulations apply to a specific class of product. In this case,

the natural health product definition is medicinal ingredient driven.

It comprises an inclusion list, outlining the medicinal ingredients that

can be contained within natural health products, and an exclusion list,

indicating those substances that are not natural health

products. Vitamins, minerals, homeopathic preparations,

traditional medicines, probiotics, amino acids, botanicals, and

essential fatty acids are included in the

definition. The definition recognizes all levels of health claims:

from risk reduction to prevention to treatment.

 

In order for vitamins and minerals to be added to the definition,

certain existing regulatory measures that restrict the health

claims that can be made for vitamins and minerals are being removed.

 

Product Licensing

 

A product licensing regime is proposed which would apply to all

natural health products. All licensed products would display a product

identification number on their labels. This number would be issued

once a product is reviewed and authorized by Health Canada.

 

Reference to a natural health product monograph

would be one basis for product authorization. Products that could not be

authorized in this way would be expected to submit sufficient evidence

of safety and efficacy (proof of health claims).

 

Under the proposed Regulations, all natural health products in Canada

will be assessed and receive a product licence before being

marketed. This will require that the manufacturer submit detailed

information on the product including: medicinal ingredients,

source, potency, non-medicinal ingredients, and recommended use.

Once authorized by Health Canada, the product label will bear a

product identification number ( " NHP " ), similar to a drug product's

Drug Identification Number (DIN). Consumers will then be

able to identify products that have been assessed and authorized by

Health Canada as safe, effective and of high quality.

 

Minimum Labelling Requirements

 

The proposed Regulations set out a number of

labelling requirements, including such information as the product name,

quantity of product in the bottle, complete directions for

use, and any cautions, warnings, contra-indications or adverse reactions

associated with the product, as well as any special storage

conditions.

 

The minimum labelling requirements will allow

consumers to make more informed

decisions about the natural health products

they buy. By using the information provided

on the label, consumers will be able to select

products that meet their own individual

needs and expectations, understand what each

product can and cannot do for them,

know how to use and store the product to

receive maximum benefit from it, and identify

any adverse reactions or other risks that might

be associated with the product.

 

For industry, the labelling requirements allow

for the opportunity to put claims on the

labels, so long as they are backed by adequate

evidence.

 

Site Licensing

 

It is proposed that all persons/organizations

in the manufacture-distribution chain be

licensed; that facilities have procedures in

place respecting distribution records and

product recalls; and where applicable,

facilities will have procedures in place for

handling, storage and delivery of their

products, and will meet Good Manufacturing Practices.

 

Any site where natural health products are

manufactured, packaged, labelled or stored

before being sold will be licensed. By doing

this, Health Canada can better enforce and

monitor the implementation of Good

Manufacturing Practices, and better ensure quality

of the products that make it to the market.

Retailers, however, will not require licences

for selling or having the products on their sites.

 

Good Manufacturing Practices

 

The Regulations set out a set of standards and

practices regarding quality assurance,

manufacture, storage, handling and distribution

respecting natural health products that must be met.

 

The Good Manufacturing Practices standards will

be required for all natural health

products being manufactured in Canada, and

those being imported from elsewhere. This

will help to ensure quality and safety of the

products being marketed in Canada.

 

Adverse Reaction Reporting

 

Under the proposed Regulations, product licence

holders would be required to monitor all

adverse reactions associated with their

product, and report serious reactions to Health

Canada on a expedited basis. Annual reports on

all adverse reactions must be maintained. The filing of

these reports to Health Canada may be required.

 

The adverse reaction reporting system will

allow Health Canada to update the safety

profiles of licensed products. It will also

alert Health Canada in a timely manner to any

potential threats to human health that might be

associated with a product, so that a

public advisory can then be issued.

 

Clinical Trials

 

Clinical trials using natural health products

that have not been authorized for sale in

Canada (i.e. have not been granted a product

licence by the Minister) will require an

application to Health Canada for authorization.

Before a clinical trial using natural health

products takes place, it will have to be

approved by a Research Ethics Board (REB),

with at least one member who is knowledgeable

in complementary or alternative health

care. Clear and transparent provisions are

included for the suspension or cancellation of

the clinical trial by the Minister if it is

believed that the Regulations are not being

followed or if participants are at undue risk of injury.

 

The clinical trials component of the

Regulations provides investigators with clear and

transparent requirements for conducting human

clinical trials with NHPs. The

requirements will ensure the safety of trial

participants while recognizing the differences

between natural health products and

pharmaceuticals. Ultimately, clinical trials will

widen our knowledge of natural health products

while providing the industry with a

means to test new products or to obtain

evidence to support new claims, if they wish.

=======================================================