OTTAWA -
Health Minister Ujjal Dosanjh today announced the launch of a new bilingual database that will
allow Canadians to search for all drugs authorized for sale in Canada since 1994.
"The Notice of Compliance database increases the transparency of Canada's drug review system and
the availability of information for Canadians," Minister Dosanjh said. "At the click of a mouse,
Canadians will have daily updates, search capability, and access to more information about drugs
than before."
The database will provide users with information such as a drug's full name, the date it was authorized,
the active/medicinal ingredient, the manufacturer, the therapeutic class of the drug, and the Drug
Identification Number, which is the numerical code assigned to drug products authorized under the Food
and Drugs Act and its Regulations. The database will be updated daily.
A Notice of Compliance is the regulatory authorization to market a new drug in Canada. Health Canada
issues such a notice to a company following the satisfactory review of a new drug submission. It
indicates that the product has met the requirements of the Regulations for safety, quality and efficacy.
Basic information about all authorized drugs currently being sold in Canada is available in the complementary
Drug Products Database already on the Health Canada website.
Comparable information on medical devices can be found in the existing Medical Devices Active Licence
Listing. This searchable online database contains information such as the company name, device name,
model/catalogue number, licence name and number, the date the licence was issued and the date it
was revised.
The information in these online databases responds to requests from medical, research and patient-advocacy
groups for more accessible data on drugs and medical devices licensed for sale in Canada.
Minister Dosanjh also announced today that Health Canada will begin posting Summary Basis of Decision
documents on its website. The Summary Basis of Decision is a key transparency initiative that summarizes
the scientific and benefit/risk considerations that factored into Health Canada's authorization to
sell a drug or medical device. Summary Basis of Decisions are intended for Canadians interested in
the basis for Health Canada's product-specific decisions for drugs and medical devices. They are
accompanied by reader's guides and background documentation.
Summary Basis of Decision documents are currently being drafted for all new active substances (biological
and pharmaceutical) and certain high-risk medical devices that were issued a market authorization
after January 1, 2005. It will take four to five months after a product has received market authorization
to prepare a Summary Basis of Decision document for posting on the Summary Basis of Decision web
page.
Important safety information that arises after a drug has received market authorization will continue
to be communicated through Dear Healthcare Professional Letters and Public Advisories.
To access the Notice of Compliance database:
www.nocdatabase.ca
For more information on Summary Basis of Decisions:
www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/proj/sbd-smd/index_e.html
The Drug Product Database can be found at:
www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index_e.html
To view the Medical Devices Active Licence Listing:
www.mdall.ca
Health Canada warnings and advisories can be accessed at:
www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/index_e.html
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Media Inquiries:
Christopher Williams
Health Canada
(613) 946-4250
Adèle Blanchard
Office of the Minister of Health
(613) 957-0200
Public Inquiries:
(613) 957-2991
1-866 225-0709
