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Found 10 records similar to Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs
Learn how we conduct inspections of human cell, tissue and organ (CTO) establishments.
Adverse reactions are undesirable effects to health products. Health products include drugs, medical devices and natural health products. Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, serums, and blood derived products; cells, tissues and organs; disinfectants; and radiopharmaceuticals.
The data extract is a series of compressed ASCII text files of the full data set contained in the Canada Vigilance Adverse Reaction Online Database. It is intended for users who are familiar with database structures and setting up their own queries. Find details on the data structure required for the data file in the Canada Vigilance Adverse Reaction Online Database - Data Structure. In order to use the data, the file must be loaded into an existing database or information system provided by the user.
The Canada Vigilance Adverse Reaction Online Database contains information about suspected adverse reactions (also known as side effects) to health products.
Although the Canada Vigilance Adverse Reaction Online Database is a relational database, there is a requirement to provide the data to users in a common format; therefore the data has been extracted into a flat file format. All files are dollar ($) sign delimited enclosed in "quotes".
The purpose of this guidance document is to provide hospitals with information that may be useful in achieving compliance with the federal regulatory requirement for hospitals to report serious ADRs and MDIs to Health Canada as outlined in section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Device Regulations.
The purpose of this guidance is to provide information to prospective cell therapy product clinical trial sponsors to assist them in satisfying applicable Federal regulatory requirements as set out in Division 5 – Clinical Trial Applications of the Food and Drug Regulations.
Cell phones, cell phone towers and antenna installations are used to enable the wireless communication needs of Canadians. Learn about the safety of cell phones, cell phone towers, antennas and 5G technology.
The human immunodeficiency virus (HIV) and the human T-cell lymphotropic virus type 1 (HTLV-1) are examples of RG3 pathogens where the pathogen risk and CL assessments have been revisited by the Agency in conjunction with HIV/HTLV specialists based on current risks associated with activities involving these pathogens. It has been determined that HIV & HTLV-1 can be safely handled at CL2/CL2-Ag with specific additional operational requirements (see Section 4.0). This Biosafety Directive is intended to provide a comprehensive overview of the risk assessment outcomes, subsequent CL decisions, and considerations that have been made for those working with HIV and HTLV-1. The Biosafety Directive for HIV and HTLV-1 is to be used in conjunction with the CBSG.
Organ donation rates have been improving in Canada but it is clear that there is more work to be done. Every year, hundreds of Canadians die while waiting for an organ transplant. With over 4,300 people in Canada waiting for a transplant right now and only a fraction of Canadians registered as donors—the need is critical.