Certified Product Information Document-Chemical Entities (CPID-CE) is a template which should be completed and filed along with the applications and submissions for drug products registered under Health Canada’s Part C, division 8 of the Food and Drug Regulations. The purpose of the document is to provide comprehensive knowledge about the key quality information related to New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) containing the drug substances and their corresponding synthetic and semi-synthetic origin products. The document is not required for Biotechnological / Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs.
The CPID-CE is a part of Notice of Compliance (NOC) and contains record of key quality information for marketing of the product at the time of NOC. During the post-approval inspections and post-approval change evaluations by the agency, CPID-CE can be treated as an official reference document. The information incorporated in a CPID-CE is the final agreed-upon key data of the drug submission review.
What should be included/excluded in a CPID-CE?
- Necessary information for CPID-CE can be directly copied from the corresponding sections of Quality and Overall Summary submitted with original drug submissions
- Tables of the document should be modified accordingly
- The Numbering of the sections should be consistent with the original submission
- For Supplements to New Drug Submissions (SNDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs), CPID-CE should include all the updates and changes post the latest update of Health Canada
- Sequential numbering of the sections is not required
- Unnecessary sections can be excluded
- Any information on executed batches should be excluded
- Sections containing drug product information can be excluded if CPID-CE is filed as a part of Type I Master File (MF)
- CPID-CE should be submitted in a word format
- CPID-CE should highlight all the strengths of single dosage form
- In case of multiple dosage forms, either individual CPID-CE can be submitted, or each dosage form can be elaborated under different sections in the same CPID-CE
- An aggregated CPID-CE can be filed for SNDSs and SANDSs
Above mentioned is the information based on the basic template of CPID-CE. It may differ from product-to-product. What are your requirements for filing a complaint CPID-CE? To get more insights, reach out to us at email@example.com.