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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, 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. F. Sjöqvist
APOLOGIES
Dr. T.B. Barragry, Prof. J.G. Descotes, Prof. M. Silbermann, Prof. K. Turnheim, Prof. D.F. Williams
COMMISSION
Ms M. de Solà (DG XXIV), Mr W. De Klerck (DG XXIV), Ms K/Howes (DG III), Mr. P. Daskaleros (DG XXIV), Mr. N. Anselmann (DG III), Mr. A. Martin (DG XXIV), Ms. S. Van Impe (DG XXIV), M. G. Fracchia (DG XII), Dr. A. Sanabria Tienza (DG XXIV)
EMEA
Mr. J. Purves
1. Adoption of the Agenda
The agenda was adopted as follows:
1. Adoption of the Agenda.
2. Approval of the Draft Summary Report of the second meeting of the SCMPMD held on 18.02.98 (XXIV/SCMPMD/98.006).
3. Update by the chairman on the latest meetings of the Scientific Steering Committee (XXIV/SCMPMD/98.028, 98.029, 98.030, 98.031, 98.033, 98.036, 98.037).
4. Information by the Commission on the legislation concerning Medical Devices.
5. 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 (SCMPMD/98.039, 98.041).
6. Discussion on the report of the Working Group concerning equivalency of alternative products to the use of intestine of animal origin for surgical sutures (XXIV/98.039, 98.041).
7. Discussion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered (XXIV/SCMPMD/98.038).
8. Discussion 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 (XXIV/SCMPMD/98.008, 98021).
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 (XXIV/SCMPMD/98.009, 98021).
10. Discussion on the report presented by the rapporteur concerning permitted colouring matters for use in medicinal products (XXIV/SCMPMD/98.040).
11. Discussion on the report presented by the rapporteur concerning the transmission of CJD by blood and its derivatives and transplantation of human organs (XXIV/SCMPMD/98.025, 98.026, 98.027, 98.032, 98.034 and 98.035).
12. Review of CPMP and CVMP guidelines.
13. Miscellaneous.
a) Antibiotic Resistance.
b) Request made by Heel concerning homeopathic veterinary drugs.
c) Request made by the Commission on "non conventional medicines".
2. Approval of the Draft Summary Report of the second meeting of the SCMPMD held on 18.02.98 (Doc. XXIV/SCMPMD/98.006).
The Draft Summary Report was approved with a slight modification.
3. Update by the chairman on the latest meetings of the Scientific Steering Committee (XXIV/SCMPMD/98.028, 98.029, 98.030, 98.031, 98.033, 98.036, 98.037).
The chairman made a brief exposure of the subject dealt with the Scientific Steering Committee at the recent meetings, and said that the main matter was as usual the subject of BSE-TSE.
Concerning the document on "Tallow and Gelatine" he stated that the Scientific Steering Committee took into account the observations made by the SCMPMD.
He also informed the Committee on the request made by the Commission to study "Antibiotic Resistance", in a multidisciplinary manner. This subject will be discussed in point 13 "Miscellaneous".
4. Information from the Commission on the legislation concerning Medical Devices.
M. Anselmann explained the subject and presented the working program of DG-III concerning the legislation on Medical Devices.
He spoke about the Directives 90/385/EEC relating to active implantable medical devices and 93/42/EEC relating to medical devices.
He also explained the Proposal for a Directive relating to in vitro diagnostic medical devices where the first application probably will be in the year 2000.
Subjects such as Definition of "Medical Device", Essential requirements for design and manufacture of medical devices, Reference to standards, CE-Marking, Conformity assessment procedures, surveillance of the market, etc., were presented.
M. Anselmann also described the rules for the protection of health and the safety of the medical devices before and after the placing them on the market. These devices are classified in two main groups: non-active devices and active devices.
Finally he explained which Working Groups and Committees at community level are working in the area of Medical Devices.
He hoped that a good collaboration would be established between the Committee and their Unit.
The Chairman said that the Committee would collaborate with DG III on all subjects for which the Committee is competent.
5. 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 (Doc. SCMPMD/98.039, 98.041).
Dr. De Jong explained the interim report concluding that the document of DG III is a good initial document, and that a more elaborated report would be presented at the next plenary meeting. This report could be the final report of the working group and be submitted for approval to the plenary of the Committee.
The Chairman said that the final report must contain more scientific basis and give the scientific bibliography.
Finally the chairman would wish that a final report be discussed at next plenary meeting.
6. Discussion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures (XXIV/98.039, 98.041).
Dr. De Jong explained that other meetings of the Working group would be necessary to draft a new report with external experts in surgery because of the lack of this expertise in the group.
The chairman responded that if the raporteur wished to extend the group to other external experts he could do.
7. Discussion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered (XXIV/SCMPMD/98.038).
Dr. Löwer explained the interim report and said that for GMP it was intended to study only the products that are included in the final medicinal product.
The Committee said that products used in the manufactured process must also be covered by these GMP.
The Chairman thanked the raporteur for this interim report and requested that a final version is made with a scientific bibliographic revision and be presented in a future plenary meeting.
Dr. Löwer said that the Working Group must meet again and that a final version could be discussed for the plenary meeting of October.
The Chairman agreed and said that at the meeting on October the report could be submitted for vote and possibly approved.
8. Discussion 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 (XXIV/SCMPMD/98.008, 98021).
This point was discussed jointly with point 9 of the Agenda because of the link between the two topics.
Prof. Preziosi presented the interim report and several members of the Committee made observations on the report.
Prof. Preziosi said that the Art. 8 of the Proposal of Directive should be modified to clarify certain concepts that must be taken into account by the Committee when giving guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
Certain members of the Committee explained that the legal texts must be analysed carefully because it is necessary to avoid conflict between the terms used in the legal basis and the report.
Other members emphasised that the concept risk/benefit will be taken as fundamental when studying of these guidelines.
The Chairman concluded that the Working Group must to continue work on the report, and that while the Committee must carefully compare the terms with the legislation, nevertheless the action of legislation is the competency of the corresponding services of the Commission.
Prof. Preziosi added that next meeting of the Working Group will held on 25 May 1998.
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 (XXIV/SCMPMD/98.009, 98021).
Prof. Preziosi said that the Working-Group appointed for the previous point is working on this subject, but that only a little progress had been made.
This is a more complicate notion than "same medicinal product" and there are not many studies on the subject.
10. Discussion on the report presented by the rapporteur concerning permitted colouring matters for use in medicinal products (XXIV/SCMPMD/98.040).
Prof. Preziosi explained the interim report and informed the Committee on the difficulty of obtaining scientific data on the subject. Next time a more complete report will be submitted to the Committee.
The Chairman and the reporteur will reflect on the help that the industry could provide concerning toxicological data on these matters.
The Working Group must meet again several times before submitting a final report.
11. Discussion on the report presented by the rapporteur concerning the transmission of CJD by blood and its derivatives and transplantation of human organs (XXIV/SCMPMD/98.025, 98.026, 98.027, 98.032, 98.034, and 98.035).
Dr Löwer said that the Working Group met on 16 April. The Group noted that several questions put by the Commission are very difficult to respond to, and some are impossible with the scientific knowledge available at the moment.
The group has already a working document available that will be transformed into a draft report at the meeting that the Working group will hold in next May.
12. Review of CPMP and CVMP guidelines.
The Chairman explained that at a first step, the Committee will identify the Guidelines interesting for the public health of consumers, and afterwards will comment on them.
The Committee agreed that Prof. Claude be responsible for the work of identifying these guidelines.
Prof. Claude accepted but said that he could not make a report before the plenary meeting of October. Nevertheless certain information could be presented to the Committee before this date.
The Chairman agreed and proposed that Dr. Löwer help Prof. Claude on the guidelines concerning excipients.
13. Miscellaneous.
a) Antibiotic Resistance.
A study on "Antibiotic Resistance" was requested by the SSC at their last meeting. The SSC agreed to make a sub-group chaired by Dr. Jones to deal with the subject.
Dr. Jones said that the contribution on this subject was required by the SSC from other Scientific Committees. Therefore he requested to set up a sub-group of the SCMPMD to cooperate with the SSC on this matter.
The Committee agreed to make a working group formed by Dr. Jones, Prof. Sjöqvist, Prof. Preziosi, Dr. Rodriguez Farré, and Dr. Barragry, chaired by Prof. Preziosi.
The first meeting will be held in London 2 June 1998.
b) Request made by Heel concerning homeopathic veterinary drugs.
After a brief discussion the Committee agreed that this is a subject already dealt with by EMEA. In the particular case of the Aristolochia the mandate to evaluate these types of products is given to the EMEA. Therefore the SCMPMD agreed that they should not revaluate this product.
c) Request made by the Commission on "non conventional medicines".
The Committee agreed to reflect on this complicated subject, given that there includes several types of so called "non conventional medicines" with very different bases.
No other points.
MEMBERS
Prof. J.M. Boeynaems, Prof. J.R. Claude, Dr. W.H. De Jong, 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. F. Sjöqvist
APOLOGIES
Dr. T.B. Barragry, Prof. J.G. Descotes, Prof. M. Silbermann, Prof. K. Turnheim, Prof. D.F. Williams
COMMISSION
Ms M. de Solà (DG XXIV), Mr W. De Klerck (DG XXIV), Ms K/Howes (DG III), Mr. P. Daskaleros (DG XXIV), Mr. N. Anselmann (DG III), Mr. A. Martin (DG XXIV), Ms. S. Van Impe (DG XXIV), M. G. Fracchia (DG XII), Dr. A. Sanabria Tienza (DG XXIV)
EMEA
Mr. J. Purves
1. Adoption of the Agenda
The agenda was adopted as follows:
1. Adoption of the Agenda.
2. Approval of the Draft Summary Report of the second meeting of the SCMPMD held on 18.02.98 (XXIV/SCMPMD/98.006).
3. Update by the chairman on the latest meetings of the Scientific Steering Committee (XXIV/SCMPMD/98.028, 98.029, 98.030, 98.031, 98.033, 98.036, 98.037).
4. Information by the Commission on the legislation concerning Medical Devices.
5. 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 (SCMPMD/98.039, 98.041).
6. Discussion on the report of the Working Group concerning equivalency of alternative products to the use of intestine of animal origin for surgical sutures (XXIV/98.039, 98.041).
7. Discussion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered (XXIV/SCMPMD/98.038).
8. Discussion 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 (XXIV/SCMPMD/98.008, 98021).
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 (XXIV/SCMPMD/98.009, 98021).
10. Discussion on the report presented by the rapporteur concerning permitted colouring matters for use in medicinal products (XXIV/SCMPMD/98.040).
11. Discussion on the report presented by the rapporteur concerning the transmission of CJD by blood and its derivatives and transplantation of human organs (XXIV/SCMPMD/98.025, 98.026, 98.027, 98.032, 98.034 and 98.035).
12. Review of CPMP and CVMP guidelines.
13. Miscellaneous.
a) Antibiotic Resistance.
b) Request made by Heel concerning homeopathic veterinary drugs.
c) Request made by the Commission on "non conventional medicines".
2. Approval of the Draft Summary Report of the second meeting of the SCMPMD held on 18.02.98 (Doc. XXIV/SCMPMD/98.006).
The Draft Summary Report was approved with a slight modification.
3. Update by the chairman on the latest meetings of the Scientific Steering Committee (XXIV/SCMPMD/98.028, 98.029, 98.030, 98.031, 98.033, 98.036, 98.037).
The chairman made a brief exposure of the subject dealt with the Scientific Steering Committee at the recent meetings, and said that the main matter was as usual the subject of BSE-TSE.
Concerning the document on "Tallow and Gelatine" he stated that the Scientific Steering Committee took into account the observations made by the SCMPMD.
He also informed the Committee on the request made by the Commission to study "Antibiotic Resistance", in a multidisciplinary manner. This subject will be discussed in point 13 "Miscellaneous".
4. Information from the Commission on the legislation concerning Medical Devices.
M. Anselmann explained the subject and presented the working program of DG-III concerning the legislation on Medical Devices.
He spoke about the Directives 90/385/EEC relating to active implantable medical devices and 93/42/EEC relating to medical devices.
He also explained the Proposal for a Directive relating to in vitro diagnostic medical devices where the first application probably will be in the year 2000.
Subjects such as Definition of "Medical Device", Essential requirements for design and manufacture of medical devices, Reference to standards, CE-Marking, Conformity assessment procedures, surveillance of the market, etc., were presented.
M. Anselmann also described the rules for the protection of health and the safety of the medical devices before and after the placing them on the market. These devices are classified in two main groups: non-active devices and active devices.
Finally he explained which Working Groups and Committees at community level are working in the area of Medical Devices.
He hoped that a good collaboration would be established between the Committee and their Unit.
The Chairman said that the Committee would collaborate with DG III on all subjects for which the Committee is competent.
5. 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 (Doc. SCMPMD/98.039, 98.041).
Dr. De Jong explained the interim report concluding that the document of DG III is a good initial document, and that a more elaborated report would be presented at the next plenary meeting. This report could be the final report of the working group and be submitted for approval to the plenary of the Committee.
The Chairman said that the final report must contain more scientific basis and give the scientific bibliography.
Finally the chairman would wish that a final report be discussed at next plenary meeting.
6. Discussion on the report of the Working Group concerning equivalency of alternative products for the use of intestine of animal origin for surgical sutures (XXIV/98.039, 98.041).
Dr. De Jong explained that other meetings of the Working group would be necessary to draft a new report with external experts in surgery because of the lack of this expertise in the group.
The chairman responded that if the raporteur wished to extend the group to other external experts he could do.
7. Discussion on the report of the Working Group concerning GMP for starting materials: list of excipients to be considered (XXIV/SCMPMD/98.038).
Dr. Löwer explained the interim report and said that for GMP it was intended to study only the products that are included in the final medicinal product.
The Committee said that products used in the manufactured process must also be covered by these GMP.
The Chairman thanked the raporteur for this interim report and requested that a final version is made with a scientific bibliographic revision and be presented in a future plenary meeting.
Dr. Löwer said that the Working Group must meet again and that a final version could be discussed for the plenary meeting of October.
The Chairman agreed and said that at the meeting on October the report could be submitted for vote and possibly approved.
8. Discussion 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 (XXIV/SCMPMD/98.008, 98021).
This point was discussed jointly with point 9 of the Agenda because of the link between the two topics.
Prof. Preziosi presented the interim report and several members of the Committee made observations on the report.
Prof. Preziosi said that the Art. 8 of the Proposal of Directive should be modified to clarify certain concepts that must be taken into account by the Committee when giving guidance on the notion of "same medicinal product" for the purpose of marketing exclusivity.
Certain members of the Committee explained that the legal texts must be analysed carefully because it is necessary to avoid conflict between the terms used in the legal basis and the report.
Other members emphasised that the concept risk/benefit will be taken as fundamental when studying of these guidelines.
The Chairman concluded that the Working Group must to continue work on the report, and that while the Committee must carefully compare the terms with the legislation, nevertheless the action of legislation is the competency of the corresponding services of the Commission.
Prof. Preziosi added that next meeting of the Working Group will held on 25 May 1998.
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 (XXIV/SCMPMD/98.009, 98021).
Prof. Preziosi said that the Working-Group appointed for the previous point is working on this subject, but that only a little progress had been made.
This is a more complicate notion than "same medicinal product" and there are not many studies on the subject.
10. Discussion on the report presented by the rapporteur concerning permitted colouring matters for use in medicinal products (XXIV/SCMPMD/98.040).
Prof. Preziosi explained the interim report and informed the Committee on the difficulty of obtaining scientific data on the subject. Next time a more complete report will be submitted to the Committee.
The Chairman and the reporteur will reflect on the help that the industry could provide concerning toxicological data on these matters.
The Working Group must meet again several times before submitting a final report.
11. Discussion on the report presented by the rapporteur concerning the transmission of CJD by blood and its derivatives and transplantation of human organs (XXIV/SCMPMD/98.025, 98.026, 98.027, 98.032, 98.034, and 98.035).
Dr Löwer said that the Working Group met on 16 April. The Group noted that several questions put by the Commission are very difficult to respond to, and some are impossible with the scientific knowledge available at the moment.
The group has already a working document available that will be transformed into a draft report at the meeting that the Working group will hold in next May.
12. Review of CPMP and CVMP guidelines.
The Chairman explained that at a first step, the Committee will identify the Guidelines interesting for the public health of consumers, and afterwards will comment on them.
The Committee agreed that Prof. Claude be responsible for the work of identifying these guidelines.
Prof. Claude accepted but said that he could not make a report before the plenary meeting of October. Nevertheless certain information could be presented to the Committee before this date.
The Chairman agreed and proposed that Dr. Löwer help Prof. Claude on the guidelines concerning excipients.
13. Miscellaneous.
a) Antibiotic Resistance.
A study on "Antibiotic Resistance" was requested by the SSC at their last meeting. The SSC agreed to make a sub-group chaired by Dr. Jones to deal with the subject.
Dr. Jones said that the contribution on this subject was required by the SSC from other Scientific Committees. Therefore he requested to set up a sub-group of the SCMPMD to cooperate with the SSC on this matter.
The Committee agreed to make a working group formed by Dr. Jones, Prof. Sjöqvist, Prof. Preziosi, Dr. Rodriguez Farré, and Dr. Barragry, chaired by Prof. Preziosi.
The first meeting will be held in London 2 June 1998.
b) Request made by Heel concerning homeopathic veterinary drugs.
After a brief discussion the Committee agreed that this is a subject already dealt with by EMEA. In the particular case of the Aristolochia the mandate to evaluate these types of products is given to the EMEA. Therefore the SCMPMD agreed that they should not revaluate this product.
c) Request made by the Commission on "non conventional medicines".
The Committee agreed to reflect on this complicated subject, given that there includes several types of so called "non conventional medicines" with very different bases.
No other points.
