News Release

2005-125
November 17, 2005
For immediate release

Minister Dosanjh announces drug authorization database and posting of summary basis of decisions

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