Performance & Innovation !
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COMPETITIVE AND BUSINESS INTELLIGENCE
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CANADIAN TPD-HPFBI GUIDANCE DOCUMENTS |
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Consultation on Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)
The concept of a SEB applies to all biologic drug submissions in which the sponsor would, based on demonstrated similarity to a reference biologic product, rely in part on publicly available information from a previously approved biologic drug in order to present a reduced clinical package as part of the submission. Full document...
Guidance for Clinical Trial Sponsors: Clinical Trial Applications
This is a guidance document for the administration of the Food and Drug Regulations Amendment (Schedule No. 1024) Clinical Trial Framework [SOR/2001-203] (also referred to as theRegulations). Full document...
Guidance Document: Human Plasma Collected by Plasmapheresis
The regulations and this guidance document apply to establishments in Canada that collect human plasma by plasmapheresis for use in the manufacture of human drugs. Plasma collected for this purpose is referred to as “source plasma”. Full document...
GMP Inspection Policy for Canadian Drug Establishments (POL-0011)
This policy describes the Health Products and Food Branch Inspectorate approach to planning and cycles of GMP inspections in relation with the issuance of Establishment Licences (EL). Full document...
Guidance document on Commercial Importation and Exportation of Drugs in Dosage Form under the Food and Drugs Act (GUIDE-0057)
This guidance document applies to drugs as defined in C.01A.001(2) that are:
• imported into Canada for commercial purposes;
• fabricated in Canada and sold for consumption outside of Canada when the package is clearly marked “Export” or “Exportation” and an Export Certificate has been issued in the prescribed form and manner, stating that the package and its contents do not contravene any known requirements of the law of the country to which it is or is about to be consigned. Full document...
Guidance for Industry and Practitioners: Special Access Programme for Drugs
This guidance document is intended to clarify the mandate, intent and scope of the SAP and outline:
- the process to be followed to access a drug that cannot otherwise be sold or distributed in Canada;
- the responsibilities of the practitioners, manufacturers, and Health Canada in that process;
- the information required to comply with Sections C.08.010 and C.08.011 of the Food and Drug Regulations.
Full document...
Guidance document on Commercial Importation and Exportation of Drugs in Dosage Form under the Food and Drugs Act (GUIDE-0057)
The purpose of this guidance is to explain the current responsibilities of establishments which import into or export drug products out of Canada under the Food and Drugs Act (FDA) or (the Act), including establishments which fabricate and package drugs for export and choose to avail themselves of the provisions of Section 37 of the said Act. Full document...
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