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Directorate-General for Health and Food Safety
List of participants
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.G. Descotes, Dr. R. Dobbelaer, Prof. J.A. Guimarães Morais, Dr. K.H. Jones, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Prof. M. Silbermann, Prof. F. Sjöqvist, Prof. K. Turnheim, Prof. D.F. Williams
APOLOGIES
Dr. T.B. Barragry
COMMISSION
Mme. De Solà, M. P. Deboyser, Mme. F. Drion, M. G. Fracchia, M. H. Buchow, Dr. A. Sanabria, M. P. Daskaleros
1. Approval of the Agenda
The agenda was adopted as follows:
1. Approval of the Agenda.
2. Approval of the Draft Summary Report of the third meeting of the SCMP&MD held on 22.04.98.
3. Discussion and possible and possible adoption of an opinion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures.
4. Discussion and possible adoption of an opinion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
5. Discussion and possible adoption of an opinion on the report concerning the transmission of CJD by blood and its derivatives, and transplantation of human organs.
6. Discussion and possible adoption of an opinion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered.
7. Discussion and possible adoption of an opinion on the report concerning permitted colouring matters for use in medicinal products
8. Discussion on the report of the Working Group concerning draft guidelines on the use of specified risk materials for the manufacture of implantable medical devices.
9. Discussion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "clinical superiority" for the purpose of marketing exclusivity.
10. Information by the raporteur on the progress of the Review of CPMP and CVMP guidelines.
11. Information by the rapporteur on the progress made by the Working Group "Antimicrobial Resistance".
12. Update by the chairman on the latest meetings of the Scientific Steering Committee.
13. Other business
2. Approval of the Draft Summary Report of the third meeting of the SCMPMD held on 22.04.98.
The Draft Summary Report was approved as figures in the document XXIV/SCMPMD/98.042 Final.
3. Discussion and possible adoption of an opinion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures.
Prof. D.F. Williams, as raporteur, explained the report made by the Working Group.
The members of the Committee made several observations, and the raporteur agreed that these would figure in the final Report.
The final Report will be sent to the members of the Plenary for written adoption, if necessary, or for adoption in the next meeting.
4. Discussion and possible adoption of an opinion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
Prof. Preziosi explained the report, and said that this draft report had taken into account the observations made by several members of the Committee.
Several observations were made during the discussion including some by the working group members themselves. Prof. Preziosi made an explicit request that all those who had contributed to the discussion send him their written proposals for amendments and modifications by the end of July. This would allow him to prepare a revised version of the document that could be submitted for final approval in the next meeting.
5. Discussion and possible adoption of an opinion on the report concerning the transmission of CJD by blood and its derivatives, and transplantation of human organs.
Dr. J. Löwer said that the Working Group was extended to 5 external experts, and had met on 18 June 1998. Progress was made in this last meeting, mainly in the first part of the report. He explained the totality of the draft report.
After the debate he promised to finalise several parts of the report pending the meeting that the Working Group will hold on 9 September1998. At the next Plenary meeting a Report containing the overview of the problem and responses to several requests made by the Commission could be approved. Other responses must be postponed to future meetings. With present scientific knowledge it might not be possible to reply to some, taking into account the epidemiological studies, the differences between CJD and nvCJD, the long period of incubation of the diseases, etc.
Dr. J. Lower requested observations and contributions to the report from the members by E-mail. Taking these observations into account a new draft will be presented during the meeting of the Working Group in September.
6. Discussion and possible adoption of an opinion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered.
Dr. R. Dobbelaer explained the draft report made by the Working Group created for this purposed.
He said that the Group considered that is more appropriate to write guidelines to evaluate the excipients that to establish a list of excipients.
Several members of the Committee agreed with the raporteur and stated that another Committee (e.g.: Regulatory Committee), following the principles giving by the Guidelines recommended by the SCMPMD could make the list. The list must be very dynamic, and changes could be made many times a year.
A new draft report will be presented in future plenary meetings.
7. Discussion and possible adoption of an opinion on the report concerning permitted colouring matters for use in medicinal products.
Prof. Preziosi, as raporteur, presented the draft report and said that for three colouring matters used in medicinal products the group had found scientific data to give an opinion, but that for the other three no toxicological data was available.
It is proposed to give an opinion concerning the first 3, and give a separate opinion for the other 3 when scientific data is available.
The document could be approved by written procedure or at the next plenary meeting.
8. Discussion on the report of the Working Group concerning draft guidelines on the use of specified risk materials for the manufacture of implantable medical devices.
This point was postponed to the meeting of October.
9. Discussion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "clinical superiority" for the purpose of marketing exclusivity.
Prof. Preziosi explained the draft report, adding that it was a preliminary report at this stage.
The members of the Committee requested several modifications and additions. Prof. Preziosi asked that these proposals be sent to him by the end of July so that he would be able to prepare a revised version of the document that could be submitted for final approval in the next meeting.
At the request of the Chairman the representative of DG III said that the report on the Guidelines will be necessary for the year 2000, that it is better to have a good report than one made urgently.
The Chairman requested that the Working Group meet again and rewrite the draft.
10.Information by the raporteur on the progress of the Review of CPMP and CVMP guidelines.
This point was postponed to the meeting of October.
11.Information by the rapporteur on the progress made by the Working Group "Antimicrobial Resistance".
Prof. Preziosi said that the Working Group met in London on 2 June 1998 to establish the activities of the group. Several external experts were proposed to join the Working Group.
Several issues were identified to begin the work.
The Working Group should meet on 1 July 1998.
12.Update by the chairman on the latest meetings of the Scientific Steering Committee.
Taking into account that the Chairman did not attend the last meeting of the Scientific Steering Committee, because of illness, this point was omitted.
13.Other business.
Not other points.
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, Prof. J.G. Descotes, Dr. R. Dobbelaer, Prof. J.A. Guimarães Morais, Dr. K.H. Jones, Dr. J. Löwer, Prof. Dr. H.W.J. Marquardt, Prof. P. Preziosi, Dr. E. Rodriguez Farré, Prof. M. Silbermann, Prof. F. Sjöqvist, Prof. K. Turnheim, Prof. D.F. Williams
APOLOGIES
Dr. T.B. Barragry
COMMISSION
Mme. De Solà, M. P. Deboyser, Mme. F. Drion, M. G. Fracchia, M. H. Buchow, Dr. A. Sanabria, M. P. Daskaleros
1. Approval of the Agenda
The agenda was adopted as follows:
1. Approval of the Agenda.
2. Approval of the Draft Summary Report of the third meeting of the SCMP&MD held on 22.04.98.
3. Discussion and possible and possible adoption of an opinion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures.
4. Discussion and possible adoption of an opinion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
5. Discussion and possible adoption of an opinion on the report concerning the transmission of CJD by blood and its derivatives, and transplantation of human organs.
6. Discussion and possible adoption of an opinion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered.
7. Discussion and possible adoption of an opinion on the report concerning permitted colouring matters for use in medicinal products
8. Discussion on the report of the Working Group concerning draft guidelines on the use of specified risk materials for the manufacture of implantable medical devices.
9. Discussion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "clinical superiority" for the purpose of marketing exclusivity.
10. Information by the raporteur on the progress of the Review of CPMP and CVMP guidelines.
11. Information by the rapporteur on the progress made by the Working Group "Antimicrobial Resistance".
12. Update by the chairman on the latest meetings of the Scientific Steering Committee.
13. Other business
2. Approval of the Draft Summary Report of the third meeting of the SCMPMD held on 22.04.98.
The Draft Summary Report was approved as figures in the document XXIV/SCMPMD/98.042 Final.
3. Discussion and possible adoption of an opinion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures.
Prof. D.F. Williams, as raporteur, explained the report made by the Working Group.
The members of the Committee made several observations, and the raporteur agreed that these would figure in the final Report.
The final Report will be sent to the members of the Plenary for written adoption, if necessary, or for adoption in the next meeting.
4. Discussion and possible adoption of an opinion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
Prof. Preziosi explained the report, and said that this draft report had taken into account the observations made by several members of the Committee.
Several observations were made during the discussion including some by the working group members themselves. Prof. Preziosi made an explicit request that all those who had contributed to the discussion send him their written proposals for amendments and modifications by the end of July. This would allow him to prepare a revised version of the document that could be submitted for final approval in the next meeting.
5. Discussion and possible adoption of an opinion on the report concerning the transmission of CJD by blood and its derivatives, and transplantation of human organs.
Dr. J. Löwer said that the Working Group was extended to 5 external experts, and had met on 18 June 1998. Progress was made in this last meeting, mainly in the first part of the report. He explained the totality of the draft report.
After the debate he promised to finalise several parts of the report pending the meeting that the Working Group will hold on 9 September1998. At the next Plenary meeting a Report containing the overview of the problem and responses to several requests made by the Commission could be approved. Other responses must be postponed to future meetings. With present scientific knowledge it might not be possible to reply to some, taking into account the epidemiological studies, the differences between CJD and nvCJD, the long period of incubation of the diseases, etc.
Dr. J. Lower requested observations and contributions to the report from the members by E-mail. Taking these observations into account a new draft will be presented during the meeting of the Working Group in September.
6. Discussion and possible adoption of an opinion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered.
Dr. R. Dobbelaer explained the draft report made by the Working Group created for this purposed.
He said that the Group considered that is more appropriate to write guidelines to evaluate the excipients that to establish a list of excipients.
Several members of the Committee agreed with the raporteur and stated that another Committee (e.g.: Regulatory Committee), following the principles giving by the Guidelines recommended by the SCMPMD could make the list. The list must be very dynamic, and changes could be made many times a year.
A new draft report will be presented in future plenary meetings.
7. Discussion and possible adoption of an opinion on the report concerning permitted colouring matters for use in medicinal products.
Prof. Preziosi, as raporteur, presented the draft report and said that for three colouring matters used in medicinal products the group had found scientific data to give an opinion, but that for the other three no toxicological data was available.
It is proposed to give an opinion concerning the first 3, and give a separate opinion for the other 3 when scientific data is available.
The document could be approved by written procedure or at the next plenary meeting.
8. Discussion on the report of the Working Group concerning draft guidelines on the use of specified risk materials for the manufacture of implantable medical devices.
This point was postponed to the meeting of October.
9. Discussion on the report of the Working Group concerning Orphan Medicinal Products: guidance on the notion of "clinical superiority" for the purpose of marketing exclusivity.
Prof. Preziosi explained the draft report, adding that it was a preliminary report at this stage.
The members of the Committee requested several modifications and additions. Prof. Preziosi asked that these proposals be sent to him by the end of July so that he would be able to prepare a revised version of the document that could be submitted for final approval in the next meeting.
At the request of the Chairman the representative of DG III said that the report on the Guidelines will be necessary for the year 2000, that it is better to have a good report than one made urgently.
The Chairman requested that the Working Group meet again and rewrite the draft.
10.Information by the raporteur on the progress of the Review of CPMP and CVMP guidelines.
This point was postponed to the meeting of October.
11.Information by the rapporteur on the progress made by the Working Group "Antimicrobial Resistance".
Prof. Preziosi said that the Working Group met in London on 2 June 1998 to establish the activities of the group. Several external experts were proposed to join the Working Group.
Several issues were identified to begin the work.
The Working Group should meet on 1 July 1998.
12.Update by the chairman on the latest meetings of the Scientific Steering Committee.
Taking into account that the Chairman did not attend the last meeting of the Scientific Steering Committee, because of illness, this point was omitted.
13.Other business.
Not other points.
