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SANDS (Supplement to Abbreviated New Drug Submission) and SNDS (Supplement to a New Drug Submission) are types of submission towards Health Canada which stand as important resources to ANDS (Abbreviated New Drug Submission) and NDS (New Drug Submission). To understand SANDS and SNDS better, let us understand ANDS and NDS first.
Abbreviated New Drug Submission (ANDS)
ANDS in Canada and ANDA (Abbreviated New Drug Application) in the United States of America (USA) are very similar to each other. ANDS is an application to Health Canada to obtain marketing approval of a generic product. It provides necessary information for the government agency to evaluate how safe a drug is in comparison to its brand name.
New Drug Submission (NDS)
The regulation and control of new drugs in the Canadian market is based on NDS, therefore, before entering the market every new drug must have an approved NDS. The documents required for NDS are required to provide all the information related to product starting from the ingredients, the results of clinical trials, reactions of the drug on humans, manufacturing etc. including complete review process.
SANDS and SNDS are submitted for any pre-approved ANDS and NDS for filing changes in packaging, labeling, dosage, ingredients or any new indications. The SANDS and SNDS notify the Canadian health authority about the changes made in the application apart from the variations already provided in the ANDS and NDS. A supplement must be submitted to describe the safety and effectiveness of changes made to the drug.
Filing SANDS and SNDS
- SANDS and SNDS are accepted following the review completion of their respective ANDS and NDS but before their Notice of Compliance is issued
- The submissions are reviewed as per the Management of Drugs Submission Policy
- NOC for SANDS/SNDS is issued along with their corresponding ANDS/NDS
To know more about what kind of information is required to compile SANDS and SNDS, how should it be submitted, reach us at sales@freyrsolutions.com