How Do Canada Drugs Receive Sale Authorization?

How Do Canada Drugs Receive Sale Authorization

?

According to Statistics Canada, drugs sales grew at an annual average rate of 7.9% between 1998 and 2005, compared with the growth of 5.3% for all retail commodities combined. The production, distribution, possession and import of various drugs and substances in Canada are governed by the provisions of the Controlled Drugs and Substances Act (CDSA). The safe manufacturing and storing of Canada drugs is covered under the drugs section of the Food & the Drugs Act of Canada. Canada Drugs: Authorization of Sale All new Canada drugs are regulated under Part C, Division 8 of the Food and Drug Regulations. Pharmaceutical companies are granted market authorization by Health Canada, the regulatory body, in several ways. Irrespective of the method of authorization, a manufacturer receives a Notice of Compliance or NOC once it has met the regulatory requirements for the safety, efficacy and quality of a product. Canada drugs include prescription and non prescription medicines, biologically derived products, such as vaccines, serums and blood derived products, tissues and organs, disinfectants and radiopharmaceuticals. Different routes are followed for the authorization of different categories of Canada drugs for sale. These include:

The New Drug Submission or NDS process for the Innovator or Brand Name Drugs.

The Abbreviated NDS or ANDS process for subsequent entry drugs or generic drugs. The submission must meet the same quality standards as an NDS and the generic product must be shown to be as safe and efficacious as the brand-name product.

The Supplemental NDS (SNDS) must be filed by the manufacturer if certain changes are made to already-authorized products. Such changes might include the dosage form or strength of the drug product, the formulation, method of manufacture, labeling or recommended route of administration. An SNDS must also be submitted to the HPFB if the manufacturer wants to expand the indications (claims or conditions of use) for the drug product.

The Therapeutic Products Directorate generally takes an average of 18 months to review a drug and to take a decision about its authorization for sale. The length of review is, however, also dependant on the product being submitted and the size and the quality of the submission. The review process before market authorization is granted may be fastened in case of certain promising Canada drugs for life threatening or severely debilitating conditions. Canada drugs that reach are marketed continue to be reviewed by the regulatory authorities. The distributors of these drugs have to report any new information related to serious side effects including the failure of the drugs to produce the desired results.

POST COMMENT

Bladder Cancer - Global Drug Forecasts and Treatment Analysis to 2020 - Volume 1 2011 Don't Do Drugs In Bangkok Depakote Lawsuits For Birth Defects Being Considered by Defective Drug Attorneys Who has access to your medical and social security identity U.S. ABP & U.S. drones flying over Mexico detecting military drug/human trafficking camps What to Do When Wonder Drugs Fail Charlie Sheen - Alcohol,Drugs and prostitutes What is meant by Medical Power of Attorney? Yeast Infection Diet - An Alternative to Prescription Drugs Short Term Medical Plans – apply today and be secured for tomorrow Medical Treatments for A Herniated Disc Why Every Canadian Pharmacy Offers Cheap Drugs The key steps to overcome stress, depression and anxiety through a drug free therapies