ectd in Canada Ginette Larocque, Purdue Pharma Canada August 23, 2016

Transcription

1 ectd in Canada Ginette Larocque, Purdue Pharma Canada August 23, 2016

2 AGENDA Eligibility for Filing in ectd Format ectd Mandatory? Structure and Content LCM Table and HC-SC 3011 Form Info Module 1 Administrative and Product Information Module 2 Summaries Module 3 Quality Module 4 Nonclinical Module 5 Clinical General Validation CTA ectd Pilot Program New!

3 Eligibility for ectd Format Transactions currently not accepted in ectd format: CTAs, CTA Amendments, CTA Notifications NHPD products OTC products Site Reference File Medical Devices Lot Release Documentation Adverse Reaction Reports provided to MHPD Response to request to Access to Information Act Annual Drug Notification Form

4 Mandatory? Strongly recommended by Health Canada; if ectd is not an option, NEES is accepted. For example, CTAs, CTA A and CTA N must be filed in NEES format. Mandate to eliminate paper by January 2017 HC is considering Jan 1, 2017 for mandatory filing of all regulatory activities via the CESG for transactions under 10 GB. (not NDS and snds) HC is considering Jan 1, 2018 for mandatory filing of all NDS, snds, ands, sands in ectd format Sponsors must follow and comply with the specifications included in the HC ectd guidances. Implementation and use of ectd format is a work in progress. Future refinements will always be made.

5 Structure and Content HC s content requirements are the same as they are for those filed in the paper based CTD format. Guidance Document: Preparation of Drug Regulatory Activities in the CTD Format Top folder is the Dossier I.D. number which starts with the letter e. Second folder is the Sequence number. First sequence number is always Cannot file Seq 0001 before Seq 0000 has been filed. Can jump into ectd stream anytime with any type of submission. Lifecycle Management Table is mandatory in Module 1. A cover letter is strongly recommended. When using the gateway, PDF version only is provided When provided on media, a paper copy is required in addition to the PDF. ectd contact in cover letter required in case validation report needs to be sent to sponsor. If the drug submission application form (form 3011) is used, its information must be included in the last page of the cover letter Other than the above, cover letters for submission to HC are standard letters with the same requirements as the FDA.

6 LCM Table and HC-SC3011 Form Info Lifecycle Management Table Information from the HC SC3011 Form

7 Module 1: Administrative and Product Information Cover Letter no scientific information If response to questions, must have name of HC reviewer requesting information in top part of letter If Form 3011 is included in submission, must have Form 3011 table included at end of cover letter. Literature references related to the Product Monograph should not be included in Module where the PM resides. They should be filed as leaf elements under the following, as appropriate: M3.3, M4.3, M5.4 all literature modules. Environmental Assessment No longer accepted in a submission. Must be provided directly to the New Substances Division at Environment Canada. Only a statement is required in the submission

8 Module 1: Administrative and Product Information, Cont d Notes to Reviewers Not a requirement, but if used, must follow guidelines A Note to Reviewer that addresses the regulatory activity as a whole should be filed under Module General Note to Reviewer. The title of the leaf should read Note to Reviewer A Note to Reviewer that is specific to a section should be filed as the 1 st leaf element in that section. e.g. a Note to Reviewer that addresses the PM should be filed under Module The title of the leaf should be Note to Reviewer PM. CPID (Certified Product Information Document) This is a summary of the QOS. Found in Module 1.3.6

9 Modules 2 - Summaries QOS granular or not, that is the question. If ICH is followed, both are acceptable, but.. HC has indicated that they prefer one document for the QOS or at most one document for the QOS Intro, one for the DS, one for the DP, and one for the Regional Information, however.. With non-granularity, LCM is difficult. HC has accepted the granular QOS for over a decade.

10 M3 - Quality YBPR Yearly Biologic Product Report When the YBPR is provided as a single document, it should be filed in M 3.2.R.4 Yearly Biologic product Reports When it s filed as multiple documents, the YBPR, Analysis of ADRs and, Recalls should be filed under Module 3.2.R.4 and all the other documents under the appropriate locations in Module 3. Master Batch Records (3.2.R.2) Must be in either French or English. If not, translation is required. One for each strength/manufacturer. Executed Batch Records (3.2.R.1) Must be in either French or English. If not, translation is required. Three EBRs for each strength/manufacturer

11 Module 4 - Nonclinical Not necessary to use a STF or a Node Extension. Study reports should be filed using a Node Extension under the following headings as applicable: Module Module Module Module Module Node Extensions should be created to support additional files to be added with subsequent regulatory transactions (sequences). Therefore, if you feel that Module 4 will be supplemented, create NEs for it as well.

12 Module 5 - Clinical Node Extensions are required. Health Canada accepts STFs instead of NEs, but only one or the other approach should be used consistently throughout the lifecycle of the dossier in the ectd format. CRFs are filed under Case Report Forms.

13 General Health Canada requires the Word version in addition to the PDF for the following documents: QOS Product Monograph CPID CS:BE (Comprehensive Summary of Bioequivalence) Responses to Questions Sponsor Attestation Checklist for ANDS Label Safety Assessment Update Sponsor Attestation Dear Healthcare Professional Letter Public Communication The Word version is placed right below the PDF version for any given document.

14 General, Cont d BE datasets are to be provided in the ASCII format, not SAS. When providing presentations for meetings with HC, PowerPoint format is an acceptable file format.

15 Transmission of Sequence to HC CESG (Canadian ESG) Strongly recommended if filing in the ectd format All submission types are acceptable for the CESG, except CTA, CTA-A, CTA-N, NDSs/ANDSs and snds/sands and DINs. Health Canada is actively working on accepting these via the CESG Other Media CD, DVD, Single and Dual Layer Recordable Digital Versatile Discs Single and Dual Layer Blue-Ray Discs USB (will not be returned to sponsor unless a pre-paid envelope is provided to HC) Portable External Hard Drive (will not be returned to sponsor unless a pre-paid envelope is provided to HC)

16 Related Sequence Number

17 Rules for Use of Operation Attributes for Specific Documents First regulatory activity everything is new. Following documents, when provided as part of any transaction, are always new. Cover Letter, Note to Reviewer, Level III Changes Form, Submission Certification Form, PSUR, RMP, etc. LCM Table New very first time, always replace with subsequent transactions CPID, Inner/Outer Labels New when provided for the 1 st time Replace when provided with subsequent transactions

18 Rules for Use of Operation Attributes for Specific Documents, Cont d Product Monograph New when provided for the 1 st time such as for NDS, snds Replace when provided in response to clarification requests, SDN, NOD, or NON. New when a pristine PM is provided for the 1 st time. The last clean and annotated PMs provided as part of that regulatory activity should be assigned the operation attribute delete. Replace when a subsequent pristine PM is provided to replace a previously approved pristine PM. There can only be ONE pristine PM in an application.

19 Bookmarks and Hyperlinks Bookmarks should be collapsed HC prefers that hyperlinks be spelled out as cross-references with explicit citations of module, and section, as appropriate. e.g. Module 3.2.P.5.1 Specifications, Table 2 Including links for web page links or addresses are acceptable in some labelling documents and literature references. Any external links to information pertinent to the review process will result in a validation failure. e.g. link to an FDA guidance

20 Validation Lorenz evalidator is used by HC. Free version works well.

21 CTA ectd Pilot Program In June 2016, Health Canada requested sponsors to apply to the ectd pilot program for CTAs. Requirements for applying: Available to attend meeting in Ottawa or by WebEx Use CESG For initial transaction, only CTAs with a 30-day approval qualify, not 7-day administrative Once in ectd, always in ectd. Including CTSI forms Application period ended July 31, 2016.