Notice. Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (ectd) electronic-only filing format

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1 Notice September 30, 2011 Our file number: Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (ectd) electronic-only filing format Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of ectd submissions. The measures outlined in this Notice are effective immediately since they do not impose an obligation but rather provide more options for submission sponsors. Sponsors are encouraged to compile submissions using the most recent Guidance Documents and Notices. This Notice is meant to be read in conjunction with the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (ectd) Format. The guidance will be changed to reflect this Notice at a future date. It is Health Canada s intention to continue to broaden the ectd electronic-only scope and future plans include those submissions currently filed in the ectd hybrid filing format. Electronic Common Technical Document (ectd) Submission Filing Format Health Canada has taken a structured approach to the adoption of ectd format for drug submissions. This approach consists of three stages and allows sponsors and Health Canada to gradually gain experience with the preparation, processing and review of submissions in ectd format. As outlined below, the three stages correspond to the three filing formats of Submissions in ectd format: 1. Co-Submission Filing Format No longer accepted by Health Canada (January 2010) 2. Hybrid Filing Format A hybrid submission is a full submission in ectd filing format that is accompanied by Modules 1 and 2 in paper based CTD format. All the submission types eligible for filing in ectd may be submitted in the hybrid filing format. /2

2 Electronic-only Filing Format Health Canada is now accepting the submission types listed below in ectd electronic-only filing format, with only the cover letter being provided in the paper format. The paper cover letter will no longer be needed once Health Canada has secure electronic transmission of data in place. Scope of Submissions in Electronic Common Technical Document (ectd) Electronic- Only Filing Format The submissions types currently accepted in ectd electronic-only filing format are listed below: Drug Notification Forms (DNF) (If related to a previously filed submission for a drug product in ectd format.); 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); 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.); Notifiable Changes (NC); and Responses to Requests for Clarification (If related to a submission filed in ectd format). New Submission Types Accepted in Electronic Common Technical Document (ectd) electronic-only Filing format are listed below: Request for Priority Review Status: New Drug Submissions (PRNDS) and Supplement to a New Drug Submission (PRSNDS); Pre-Submission Meeting Information; Drug Identification Number Application (DINA); Drug Identification Number Application - Biologic (DINB). The following submission types are eligible for filing in ectd format however are not currently accepted in ectd electronic-only filing format, and therefore should be submitted in hybrid filing format: New Drug Submission (NDS); Abbreviated New Drug Submission (ANDS); Supplement to a New Drug Submission (SNDS); /3

3 - 3 - Supplement to an Abbreviated New Drug Submission (SANDS); Periodic Safety Update Reports (PSURs) requested during the pre-market review process by Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD). Other Pharmacovigilance data requested by MHPD; o Risk Communication documents [for example (e.g.), Health Care Professional Letters, mailing lists] The ectd copy should be sent to the Submission and Information Policy Division (SIPD), with an electronic copy being submitted directly to MHPD via . The ectd copy should be sent the same day as the electronic copy is ed. o Post Marketing Surveillance [e.g., Safety or Summary Report, Council for International Organizations of Medical Sciences (CIOMS), Line Listings, Registry Reports or Clinical Study reports, Patient Exposure Data] o Benefit-Risk Assessments o Signal Work Up o Response to MHPD Requests for Additional Information o Notification of change in benefit-risk profile (under sections C (3) and (4) of the Food and Drug Regulations) Notes i. At this time any information related to the above list of submission types not accepted in electronic-only filing format, other than responses to Requests for Clarification, should be submitted in hybrid filing format, for example, responses to Notice of Non- Compliance (NON), Notice of Deficiency (NOD), and Screening Deficiency Notice (SDN). When the above submission types are accepted in electronic-only filing format, these responses will also be accepted in electronic-only filing format. ii. iii. The cover letter and electronic media must be sent directly to SIPD in order to ensure timely processing of these submissions. The Letter of Attestation is not required for submissions or sequences in the ectd electronic-only filing format. The following submission types are currently not accepted in the ectd format: Clinical Trial Applications, Amendments or Notifications (CTA, CTA-A, CTA-N); Natural Health Products (NHP) applications; Drug Master Files (DMF); Site Reference Files (SRF); Medical Devices - Licence Applications or Amendments (LAp or LAm); Lot release documentation. /4

4 - 4 - Technical Requirements for new submission types in electronic-only filing format Pre-Submission Meetings The Pre-Submission Meeting packages, slide deck and minutes should be filed as leaf elements under the m1-2-8-other-application-information subheading, at this time. For all leaf files provided as part of the Pre-Submission Meeting Package, the operation attribute in the leaf element should be new, with the possible exception of the Life Cycle Management (LCM) table. When a document is revised in relation to the pre-submission meeting, the operation attribute should be replace. When submitting the subsequent NDS/ANDS: The operation attribute in the leaf element should be new for all leaf files provided, with the exception of the Life Cycle Management (LCM) table. The NDS/ANDS should be a stand alone submission. Any information provided in relation to pre-submission meeting, if needed in the NDS/ANDS, should be resubmitted, with the exception of meeting minutes, which may be hyperlinked. When submitting the subsequent SNDS/SANDS: The operation attribute replace should be used as needed in relation to the previous sequences (with the exception of any sequences related to pre-submission meetings). If this is the first submission in ectd format, the operation attribute in the leaf element should be new for all leaf files provided, with the exception of the Life Cycle Management (LCM) table. The SNDS/SANDS should be a stand alone submission. Any information provided in relation to pre-submission meeting, if needed in the SNDS/SANDS, should be resubmitted, with the exception of meeting minutes, which may be hyperlinked. Sponsors may be required to provide printed copies of the Pre-Submission Meeting Package, upon request, as per Appendix E of the Preparation of Drug Submissions and Applications in the Electronic Common Technical Document (ectd). /5

5 Priority Review Requests The Clinical Assessment Package (CAP) filed to support a Priority Review Request should be filed as leaf elements under the m1-2-8-other-application-information subheading, at this time. When the related submission is filed, the priority review acceptance letter should also be filed under the m1-2-8-other-application-information subheading. Application for a DINA or DINB The information provided in support of a DINA or a DINB application should be in the CTD format as outlined in the 2003 Draft Guidance to Industry: Preparation of New Drug Submissions in the CTD Format. Sponsors filing a DINA/DINB application in ectd format for the first time are strongly recommended to request a technical pre-submission consultation with Health Canada. Response to a Request for Clarification (Clarifax) Process The response to a Request for Clarification in ectd format should be sent directly to SIPD. Though not mandatory, it is suggested that a summary of the response in Question and Answer format be faxed directly to the requestor. To ensure compliance with the due date, the electronic response in ectd format should be sent the same day as the summary is faxed. Responses to a Request for Clarification should otherwise conform to procedures described in Health Canada's Guidance for Industry: Management of Drug Submissions, Section 5.2.6, "Responses to Clarification Requests". Cover Letter for Submissions in Electronic Common Technical Document (ectd) format Health Canada strongly recommends that all drug submissions and subsequent additional information in ectd format be accompanied by an administrative cover letter in both paper and portable document format (PDF). In addition to the content recommended by ICH, Health Canada also requires the following: A. All cover letters should clearly state what is being submitted, including reference to the request letter (if applicable) and a brief description of the package. Submission or application type Control number Brand name Manufacturer / applicant's name Central Registry (CR) file number Any cross-referenced submission or application should be clearly stated o Date the submission or application was approved /6

6 - 6 - Contact information for the ectd publisher, including the address where the Validation Report should be sent, as needed. ectd identifier Sequence number If a Periodic Safety Update Report (PSUR) is to be submitted, one of the following types should be indicated in the cover letter: o Requested AD HOC PSUR - submitted as a one-time submission request o Voluntary PSUR - unsolicited submission o Requested Periodic PSUR - requested by Health Canada, e.g., Risk Management Plan (RMP) follow-up or post-authorization commitment; o PSUR-C (confirmatory) - submitted to support the fulfillment of a Notice of Compliance with Conditions (NOC/c) B. A table should be inserted at the end of the cover letter for submissions that contains the HC- SC3011 form information as structured below: Type of Submission Number of Volumes/Disks Drug Product Brand Name Common Name Drug Identification Number Owner -Company Name -Legal Address Proposed Indication Box 5 of HC-SC3011 form Box 6 of HC-SC3011 form Box 64 of HC-SC3011 form Box 8 of HC-SC3011 form Box 9 of HC-SC3011 form Part A Box 11 of HC-SC3011 form Boxes of HC-SC3011 form Box 67 of HC-SC3011 form Dosage Form Box 60 of HC-SC3011 form Route of Administration Box 63 of HC-SC3011 form Medicinal (active) Ingredients Box 56 of HC-SC3011 form Ingredient Name Strength Unit Per Calculated as Base (Yes/No) C. The PDF cover letters include, as Appendix 1, the Life Cycle Management Table, discussed in Section 4.3, "Life Cycle Management. This Appendix should be submitted as a separate file. /7

7 - 7 - D. For submissions in ectd electronic-only filing format, please indicate in bold capital letters ectd ELECTRONIC-ONLY FILING FORMAT in the subject line of the cover letter. Packaging of Submissions in Electronic Common Technical Document (ectd) format The following are requirements for the packaging and labeling of the ectd submissions in the Hybrid and the Electronic-Only Filing Formats. Hybrid Filing Format o A shipping box marked ectd containing the paper copy of Modules 1 and 2, as applicable, and the compact dics/digital versatile discs (CD/DVD). Electronic-Only Filing Format o An envelope marked ectd containing the cover letter and the CD/DVD(s). If you have any questions regarding the content of this notice, please contact: Submission and Information Policy Division (SIPD) Therapeutic Products Directorate Health Canada Finance Building 2, Address Locator 0201A1 101 Tunney s Pasture Driveway Ottawa, Ontario K1A 0K9 ereview@hc-sc.gc.ca