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Fourth meeting of the EU eCTD NMV/RPS subgroup
                th
Bonn, October 7 2009

Participants:
Regulators: Harald Binder, Martin Georgiev (AGES), Klaus Menges (BfArM), Stan Van Belkum, Ricco
Van den Hoorn (MEB), Claire Holmes (EMEA), Miguel Bley (AFSSAPS)
Industry: Geoff Williams, Joerg Lautz, Raun Kupiec, Leigh Sandwell (EFPIA), Remco Munnik, Vito
Strasberger (EGA), Andreas Franken (AESGP), Alain Seront (EuropaBio)

Introduction and purpose
The main objectives of the fourth meeting of the EU eCTD NMV/RPS subgroup were:
    1. To provide feedback on the HL7 Atlanta meeting
    2. To further discuss and finalise specific EU requirements for eCTD NMV/RPS
    3. To discuss the way forward with the EU input in the SDO-process and provide next steps
One item added to the agenda: overview of status of the six eCTD/RPS topics.
This summary report will follow the agenda of the meeting:

3) Summary report and action items Vienna meeting July 6 2009
Three minor remarks:
     Page numbering is missing
     Remark in Dutch on page 2 should be deleted
     Footnote page 3: ICH meeting is in St Louis, not in Louisiana
The Summary report was adopted.

The majority of the action items have been finalized nr. 39 (on agenda), 5, 36, 37, 20 (on agenda), 21,
38/39, 40, 41; additional remarks provide below:

Nr.     Remark                                                                                  Decision
                                                                                                on action
1.      Still no final answer from the Commission, it is under debate; there seems to be        Continue
        some interest from the veterinary sector
3.      Version 3.0 of the RDM will be published in 2010; participants would still like to      Continue
        have also version 2.0 available
                                                             th
        Post Meeting Note: In a meeting with EFPIA on 14 October, Hans-Georg Wagner
        indicated that v2 of the RDM would be published “soon”.
38/39   The Discussion/Whitepaper has been distributed and explained, also from a               Delete
        process/procedural point of view; no additional remarks on the text; the document
        can and will be used by the different stakeholders
40      The idea of a HMA-workshop has been discussed (based on the document under              Continue
        action 38/39) in the HMA Management Board; the HMA are not resistant to the
        idea, the industry in-put should be further explained; target date is the second HMA
        meeting in Spain (12-13 April 2010); further cooperation in the group is necessary
21      No further work necessary, keep the glossary as is; final distribution (action Klaus)   Delete
41      There is a single page document from TIGes on this topic; will be distributed           Delete
        (action Geoff); as a spin-off, the meeting expressed the wish for a publication-
        forum for the group; the EMEA eSubmission website was suggested with as first
        item an introduction and the single page TIGes document (action Claire)
43/25   ICH SENTRI group will discuss this item in St Louis; await the outcome of this          Continue
        discussion before further discussion in the eCTD/RPS Support Group                      (43)
44      Inventory of current EU status with regard PDF version has been completed; will be      Continue
        submitted to ICH (action Miguel), however, no EU harmonised view on
        acceptance of ISO 32000 standard; ICH discussion awaited
38      A first version of a position paper had been distributed and is on the agenda;          Continue
        editing will be taken over by Stan
46      A doc with the Japanese view on LCM was distributed; seems to be a basis for            Continue
        further EU discussion (generate examples for the theoretical options); to bring this
        items further, activities and planning needs to be agreed



                                                     1
4) Feedback HL7 Atlanta meeting
Limited information available since none of the participants of the group were at this meeting. General
messages:
    - ICH requirements have been fed into the process and are being discussed
    - the RPS group seems to be in „a hurry‟ to process the ICH requirements, though there is no
        particular reason for this except to report back to the next ICH Meeting, and project governance
        remains unclear
    - RPS 2.0 continues in its own pace targeting for FDA‟s deadline of 2011
    - RPS 3.0 should start officially in January 2010; this 3.0 version should lead to the eCTD NMV
    - PhRMA ERS is in the process of creating a special subgroup to pilot and test the RPS 2.0
        standard in the US. They have suggested getting involvement from other parties as a possible
        preparation for the ICH input to RPS 3.0.

Background documentation (several presentations) will be provided (action Geoff)


5) EU Specific requirement: regulatory activity
Several lists with examples of regulatory activities have been distributed and a first version of a proposal. A
first version of a definition of “regulatory activity” has been drafted by the group. The text will be
incorporated in the document as provided by Andrew. The following statements have been confirmed:
      - A regulatory activity has a status and this status is transparent to the applicant/MAH; specific
          attention to status transitions should be given
      - Individual document will for the moment being not have a status; the status can be derived form
          the combination of the status of the activity and the document operation attributes
      - The new variation guideline should receive specific attention
Further editing of the document will be done by Stan and a new version provided in two weeks (action
Stan)
The excel issue list has been discussed. Several questions relate to the scope; it was decide to do a first
sorting based on the scope before other issues will be discussed (action Raun); the following was
decided:
      - The scope is limited to human medicines
      - The scope for human medicines should not be limited to MAA activities but should be as wide as
          possible
      - However, priority should be given to MAA activities
      - The following priorities are defined: “in scope MAA”, “in widest scope” and “not in scope”


6) EU Specific requirement: active substance manufacturers
At several levels and occasions currently actions with regard to master files are being discussed, amongst
others EMEA, QWP, EDQM and Interlinking group. For the eCTD NMV/RPS Subgroup there is no
immediate action defined other than following the developments carefully. Difficulties are around the closed
and open parts and the exact content of master files. From a regulatory perspective is has been clear for
some years: master files should follow the CTD structure and should be in an electronic form.

7) Status six ICH topics

Topic                   Status                                                                  Action
Module 1 metadata       Current envelope is fine for EU with minor changes i.e.                 YES
                        identification of application, sender and receiver; all other
                        information should be extracted from the eAF in Europe; some
                        debate on the details of sender/recipient, see action item list
Doc & file Life Cycle   General position: remove “append” and keep what we have.                YES
                        Based on JP document activities and planning should be agreed:
                        - 2 weeks comments on JP document and send to Geoff (action
                        all)
                        - compile all comments and produce a summary for EU use, with
                        any proposals for EU specific changes (action Geoff)
                        - Compilation and story boards



                                                      2
                        See action item list
Two-way comm            EU comments/issues in ICH requirements: the requirements will         NO
                        not be mandatory
Integrity, security &   MD5 discussion in ICH: EU happy with current type and version of      NO
user friendliness       checksum; if ICH decides for a different checksum type no
                        particular objection from EU
Compatibility           EU comments/issues in ICH requirements                                NO
Validation              Clarification one item still necessary, (action Miguel), see action   YES
                        item list

8) Project plan EU input in development of RPS and eCTD NMV
The second version of the project plan has been shortly discussed. The group suggested that a business
case should be distilled from the project plan. This business case should be more advanced as compared
with the project plan in the following components:
      The business case itself should be stronger
      Financial foundations
A version of this business should be provided to the group before 1-11-09 with a review time of the group
until 6-11-09 (action Stan and all). After finalisation this document should be used by the different
stakeholders for internal use and in the discussion around the strategic planning of the EMEA and HMA.


9) Short inventory of issues around the implementation of the new variation guidelines
The consequences of the new variation guideline will be part of the document on regulatory activity, see
action item list.


10) Next steps
                                                                                               th
See action item list. The next meeting will probably be hosted by EMEA with a target date of 25
November (action Claire/Stan)




                                                     3
Action items

No    General Actions                                                     Responsible   Deadline
1.    Confirmation from EC if RPS in EU will have the widest scope        Stan          1-10-09
      (including vet, devices) or is it limited to human medicines
39    Inventory issues with ASMF                                          Maren         1-10-09
3.    Can the Reference Data Model 2.0 be made public?                    Stan          25-11-09
5.    Impact analysis of RPS 2 and eCTD
36    Distribution of M2 SC presentation Yokohama                         Geoff         asap
37    Availability group in week 5-9 October                              Stan/Klaus    asap
47    The following documents should be distributed:
           - final version of glossary                                    Klaus         asap
           - relevant documents on RPS progress                           Geoff         asap
           - single page document TIGes on tools                          Geoff         asap
           - XML initiatives (e.g. DITA)                                  Andreas       asap
48    Use the eSubmission website of EMEA as publication forum of         Claire        asap
      this group; specific eCTD NMV/RPS subgroup page; further
      content to be discussed next meeting
51    Business case eCTD NMV/RPS                                          Stan          1-11-09
                                                                          all           6-11-09
52    Explore options for a meeting on 25/11 in London                    Claire/Stan   asap
No    Actions on next meeting NMV eCTD                                    Responsible   Deadline
20.   Second version project plan for NMV eCTD/RPS                        Stan          August
38    Draft a first version white paper and distribute for comment        Stan          August
39    Present white paper to stake-holder/organisations                   all           september
40    Further arrangements of HMA workshop April 2010                     Stan
21.   Second draft glossary                                               Klaus         1-10-09
41    Gathering initial requirements for review tools (Lorenz & Extedo)   Claire        1-10-09
42    Proposal on folder and file names (CON 17/24) to TIGes              Miguel        25-11-09
43    XML for content documents: wait for ICH discussion                  Miguel        25-11-09
44    EU acceptability of PDF ISO 32000                                   Miguel        25-11-09
53    EU inventory on PDF to ICH Sentri group                             Miguel        asap
45    Necessary information on envelope with regard to                    all           1-10-09
      sender/recipient (e.g. company info and regulatory agency info)
No    Actions on two-way communication                                    Responsible   Deadline
24.   Described your internal business process at high level for an       Remco/Ricco   25-11-09
      application for a new product
No    Actions on document and file life-cycle                             Responsible   Deadline
25.   Structured data versus documents: TIGes discussion                  Miguel
35    Provide information on various initiatives around documents and     Andreas       asap
      XML (e.g. DITA) to the group
40    Examples (if any) of related regulatory activities (NEW 25)         all           1-10-09
46    Goal: generate EU examples of theoretical options for LCM;
      - Comments on JP document                                           all           1-11-09
      - Compilation comments and summary of document                      Geoff         25-11-09
      - first version EU story boards                                     Geoff         25-11-09
No    Actions on module 1 meta-data                                       Responsible   Deadline
49    EU definition of sender/recipient envelope                          Claire        25-11-09
38    Finalisation EU requirement on regulatory activity; new version     Stan          1-11-09
50    Sorting on priority excel issue list                                Raun          25-11-09
No    Actions on validation                                               Responsible   Deadline
31.   Further comment on specific question                                Miguel        asap




                                                     4
Clean version of action list (including a new column for subject)

No    General Actions                                             Subject       Resp.         Deadline
1.    Confirmation from EC if RPS in EU will have the             General       Stan          1-10-09
      widest scope (including vet, devices) or is it limited to
      human medicines
3.    Can the Reference Data Model 2.0 be made public?            General       Stan          25-11-09
47    The following documents should be distributed:              General
          - final version of glossary                                           Klaus         asap
          - relevant documents on RPS progress                                  Geoff         asap
          - single page document TIGes on tools                                 Geoff         asap
          - XML initiatives (e.g. DITA)                                         Andreas       asap
48    Use the eSubmission website of EMEA as publication          General       Claire        asap
      forum of this group; specific eCTD NMV/RPS
      subgroup page; further content to be discussed next
      meeting
51    Business case eCTD NMV/RPS                                  General       Stan          1-11-09
                                                                                all           6-11-09
52    Explore options for a meeting on 25/11 in London            General       Claire/Stan   asap
40    Further arrangements of HMA workshop April 2010             General       Stan
42    Proposal on folder and file names (CON 17/24) to            Construct     Miguel        25-11-09
      TIGes
43    XML for content documents: wait for ICH discussion          File format   Miguel        25-11-09
53    EU inventory on PDF to ICH Sentri group                     Miguel        asap
44    EU acceptability of PDF ISO 32000                           File format   Miguel        25-11-09
45    Necessary information on envelope with regard to            Envelope      all           1-10-09
      sender/recipient (e.g. company info and regulatory
      agency info)
24.   Described your internal business process at high            Two-way       Remco/Ric     25-11-09
      level for an application for a new product                                co
35    Provide information on various initiatives around           File format   Andreas       asap
      documents and XML (e.g. DITA) to the group
46    Goal: generate EU examples of theoretical options for       LCM
      LCM;
      - Comments on JP document                                                 all           1-11-09
      - Compilation comments and                                                Geoff         25-11-09
      - first version EU story boards                                           Geoff         25-11-09
49    EU definition of sender/recipient envelope                  Envelope      Claire        25-11-09
38    Finalisation EU requirement on regulatory activity;                       Stan          1-11-09
      new version
50    Sorting on priority excel issue list                        Envelope      Raun          25-11-09
31.   Further comment on specific question                        Validation    Miguel        asap




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