24.08.2010

CA: Update from Health Canada regarding scope of submissions being accepted in eCTD format and acceptance of electronic-only submissions

Health Canada has released an update regarding the scope of submissions currently accepted in eCTD format. Furthermore selected submission types will be accepted in eCTD-only format without requiring additional paper copies (see link at the end of this article).

In addition to the already accepted submission types (see section 2.2 of the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format) the following submission types are accepted in eCTD format with immediate effect:

Notifiable Changes (NC) (Please note: Previously, NCs were only accepted when related to previously filed submissions in eCTD format)
Drug Notification Forms (DNF) (If related to a previously filed submission for a drug product in eCTD format.);
PSURs* submitted to the Marketed Health Products Directorate (MHPD)
Risk Management Plans (RMP) submitted to the Marketed Health Products Directorate (MHPD);
Yearly Biologic Product Reports (YBPR)
Request for Priority Review Status: New drug Submissions (PRNDS); and Supplement to a New Drug Submission (PRSNDS)

*In order to facilitate appropriate tracking of PSURs, Health Canada is requesting that the nature of the PSUR be reflected in the cover letter. Therefore, the corresponding section 3.1 Cover Letter of the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format will be changed as follows:

"All drug submissions and subsequent additional information (solicited and/or unsolicited information) in eCTD format should be accompanied by an administrative cover letter in both paper and portable document format (PDF). The cover letter should always state whether the information provided is a drug submission, by indicating the submission type such as NDS, ANDS, SANDS, NC, PSUR (i.e. Requested AD HOC PSUR, Voluntary PSUR, or Requested Periodic PSU), etc., or additional information such as Response to a Clarification Request, Response to a Notice of Non-Compliance (NON), Response to a Notice of Deficiency (NOD), etc. concerning a submission"

Health Canada now accepts selected submission types listed below in eCTD electronic-only** filing format

Drug Notification Forms (DNF) (If related to a previously filed submission for a drug product in eCTD format.) Note: Since the Drug Notification Form (DNF) does not contain confidential data, Health Canada recommends that the DNF and the accompanying supporting data in electronic format be submitted via e-mail to SIPD-DINrequest@hc-sc.gc.ca. Further detail is provided in the Notice accompanying the DNF. A paper cover letter is not necessary if sponsors are submitting the DNF by email.
Periodic Safety Update Reports (PSUR) submitted to the Marketed Health Products Directorate (MHPD);
Risk Management Plans (RMP) submitted to the Marketed Health Products Directorate (MHPD); and
Yearly Biologic Product Reports (YBPR);
Forms summarizing the Post Notice of Compliance (NOC): Notices of Change (Level III) (If related to a previously filed submission for a drug product in eCTD format.)

**Health Canada strongly recommends to provide a paper cover letter in addition to the electronic submission on CD/DVD. Further paper copies are not requested.

[Source: Health Canada website]

Links:

www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/ctd/ectd/ectd_scope_notice_avis-eng.pdf

<- Zurück zu: News