natgillin/translations-raw huggingface dataset:
ηλέτ ατΣ ςητ ςαίσαγρε ςεδά ο ςιτσ ιακ
Discussions began on how best to make this model application tracking system freely available to regulatory authorities not only in the European region and throughout the world.
ητσ ιατεχέραπ υοπ ηξιρήτσοπυ νητ ορετόσσιρεπ η όκα CPMP
The exchange between the EMEA and authorities of third countries continued in 2000, with national experts from both Japan and US spending extended periods of time at the Agency.
ςησιρώνγανα ςαίαβιο α ςητ ςησνυλόκυειδ αδά ο νητσ ηξιρήτσοπυ εχίεραπ ςήτυα
The EMEA was pleased to welcome delegations from China, Kuwait, Malta, Russia Taiwan and US during the year.
ςητ ςησινό ρανε ςετητόιρητσαρδ ςίενθειδ ιακ ςέκϊαπωρυε ςιτ εξιρήτσ
Details of activities within the International Conferences on Harmonisation for human and veterinary medicines (the ICH and VICH initiatives) can be found in Chapters 2 and 3 of the report.
Anthony HUMPHREYS
21 EMEA General Report 2000
Patrick LE COURTOIS AMATI
22 EMEA General Report 2000
νώκι ηχ νωέν αέ οτ ςονε άτσϊορΠ
Chapter 2 Medicines for human use
αέ οτ ςονε άτσϊορπ ςήτωρηλπανΑ
Overview of the Unit for the Evaluation of Medicines for Human Use in 2000 Head of Unit Head of Sector for regulatory affairs and
Noël WATHION Noël WATHION
Noël WATHION
αέ οτ ςονε άτσϊορΠ ςαδάνο ςονε άτσϊορΠ
pharmacovigilance Deputy Head of Sector Head of Sector for biotechnology and biologicals Deputy Head of Sector Head of Sector for new chemical substances Deputy Head of Sector
EMEA/ MB/ 050/ 00 αέ οτ ςονε άτσϊορπ ςήτωρηλπανΑ Marisa PAPALUCA AMATI αέ οτ ςονε άτσϊορΠ Isabelle MOULON αέ οτ ςονε άτσϊορπ ςήτωρηλπανΑ
Noël WATHION Isabelle MOULON John PURVES Marisa PAPALUCA AMATI Patrick LE COURTOIS Anthony HUMPHREYS
νωτνόϊορπ νώκιτυεκα ραφ
During 2000 the Unit for the Evaluation of Medicines
άτσϊορΠ
for Human Use:
νητ ιακ ησηνπύργαπεοκα ραφ νητ αιγ ςαέ οΤ αέ οτ ςονε άτσϊορΠ Anthony HUMPHREYS ςηξιρήτσοπυ ςήκιτωναγρο ιακ νωεσέθοπυ νώκιτσι θυρ ςαέ οΤ ςαδάνο ςονε άτσϊορΠ
• management and follow-up of marketing authorisation applications under the centralised procedure • provided scientific advice • provided support to the Committee for Proprietary Medicinal Products, Committee on Orphan Medicinal Products and to protocol assistance • continued supporting pharmacovigilance and post-marketing maintenance of authorised medicinal products • managed Community referrals and arbitrations arising from the mutual recognition procedure • provided support to European and international harmonisation activities of the CPMP and its working parties • provision of support to the Mutual Recognition Facilitation Group
νωκά ραφ νωτ ατητόιοπ νητ αιγ ςαέ οΤ αέ οτ ςονε άτσϊορΠ Patrick LE COURTOIS ακα ράφ άναφρο ατ ιακ νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ αιγ ςαέ οΤ ςαδάνο ςονε άτσϊορΠ
Developments in the workload of the Unit, in particular relating to orphan medicinal products and post-marketing activities, lead to discussions in 2000 concerning the restructuring of the Unit.
] ίεθωνιοκανα αν ιατιεκόρΠ ςαίεδα ςησηγήροχ ςητ ιατίεγηορπ
The proposed new structure of two Units is intended to facilitate the handling of an increasing workload and to further enhance support for the CPMP and its working parties.
ιατεπέ υοπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ
The following nominations for the posts in the two new Units were announced at the end of 2000:
υοπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ
23 EMEA General Report 2000
νώκιτυεκα ραφ ησηγόλοιξα νητ αιγ αδάνοΜ 26/ 97 αδίλεΣ
Unit for the Pre-authorisation evaluation of medicines for human use
νώκιτυεκα ραφ ησηγόλοιξα νητ αιγ αδάνοΜ
[To be announced] Head of Unit Sector for scientific advice and orphan drugs Patrick LE COURTOIS Head of Sector Sector for quality of medicines John PURVES Head of Sector Sector for safety and efficacy of medicines
ησεθκέ αισήτΕ 2000
Isabelle MOULON Head of Sector
ςετητόιρητσαρδ ςέκιδιΕ
Marisa PAPALUCA AMATI Deputy Head of Sector
ηση όνιξατ ςορπ ςετητόιρητσαρδ ςέκιδιΕ 21% 13%
Unit for the Post-authorisation evaluation of medicines for human use
ησηγόλοιξα ήκιχρΑ οτ άτακ ησήρχ ηνιπώρθνα 2000
Noël WATHION Head of Unit Sector for regulatory affairs and organisational support Anthony HUMPHREYS Head of Sector Sector for pharmacovigilance and post-authorisation safety and efficacy of medicines
νωέ οτ ολονύσ (αδοξέ άκινεΓ
[Post vacant] Head of Sector
ησεθκέ αισήτΕ 2000
Sabine BROSCH Deputy Head of Sector
EMEA/ MB/ 050/ 00 ςιεσήιο ποπορτ αιγ ιακ
ActiTrak data for human medicines evaluation in 2000
13
Overheads (all sectors) 13%
4
Initial evaluation 21% Special activities to be earmarked 9%
Α ςορέΜ
Specific post- authorisation 9%
ςιεσήτια ςέκιτπονυσ ιακ ςιεσάτκεπε αιγ ςιεσήτιΑ
EU general contribution 21% Maintenance activities 17% Administrative charges 2%
95
Arbitration/ referrals 3%
Β ςορέΜ
Scientific advice 5%
384 *
24 EMEA General Report 2000
69
2.1 Operation of the Committee for Proprietary Medicinal Products
ΙΙ υοπύτ ςιεσήιοποπορΤ
Chairman of the CPMP Vice-chairman of the CPMP
205
Jean-Michel ALEXANDRE Mary TEELING (January-September 2000) Hans van BRONSWIJK (September-December 2000)
207
Details of membership of the Committee can be found in Annex 4.
108
Total
Β ςορέΜ
Centralised procedures Applications received
816
1998
106
1999
50
2000
Α ςορέΜ
1995-2000
Ι υοπύτ ςιεσήιοποπορΤ
Part A Part B Withdrawals
15
12 33
19
19 32
17
17 37
176 *
278
11 νόϊορπ άνα νακηθίρκγε υοπ
Part A Part B Opinions adopted by product
12
8 12
Β ςορέΜ
0 11
ςιεσρύσοπΑ
Part A Part B Opinions adopted by substance
278
11 30
17
9 17
19
20 30
12
176*
νακηθφήλαραπ υοπ ςιεσήτιΑ
Part A Part B Type I variations
1995 -
11 19
2000 2000
8 15
1999
15 14
1998
134*
ςείσακιδαιδ ςέκιρτνεΚ
Part A Part B Type II variations
ο λονύΣ
50 108
4.
68 207
α ητράραπ οτσ ιατνοχέραπ ςήπορτιπε ςητ ηλέ ατ ε άκιτεχσ αίεχιοτσ ήρε οτπεΛ
106 205
2000)
816
ςοιρβ έκε∆ ςοιρβ έτπεΣ –
Part A Part B Extension & abridged applications
Hans van BRONSWIJK (
26 40
Mary TEELING (
48 61
–
69 95
CPMP
384*
ςητ ςορδεόρΠ
Part A Part B
νωτά σαυεκσοιδΙ νώκιτυεκα ραΦ ςήπορτιπΕ ςητ αίγρυοτιεΛ
11 4
2. 1
6 13
28/ 97
2 5
αδίλεΣ
84
ησεθκέ αισήτΕ 2000
* These figures include negative opinions given for 6 products (representing 4 substances), and for 2 variations.
EMEA/ MB/ 050/ 00
Performance indicators
νώι ριατε αί σεθσο ρΠ
The level of satisfaction of both CPMP members and applicants with most aspects of the centralised procedure was acknowledged to have reached a consistently high level.
ςησαφόπα ςησοδκέ αίσακιδαι∆
It was decided to revise the focus of the annual performance survey in 2001.
ΑΕΜΕ υοτ ςη ώνγ ςητ ςησοδκέ ςητ ιατεπέ
The EMEA continued to meet its performance target of adopting all opinions on the evaluation of medicinal products within the 210-day time frame.
υοπ οιδάτΣ
25 EMEA General Report 2000
ςησηγόλοιξα ησάΦ
Average number of days for centralised procedures 1995-2000
2000 1999
500
1998
450
1996
59
1995
179
185 42 83
Days
178 32 86
350 300
169 40 79
119
189 45 119
119
148 179
139
139
148
119
250
59
79
400 500
86
1995 - 2000
70
,
71
,
200
νώρε η νωτ
150
.
45
210
40
οσότ
32
20
42
29/ 97
38
UK
45
S
100
F
50
I
189
N
169
P
178
A N
185
N
183
L L
178
I 1995 - 2000
1995
IRL IS F
1996
EL
1997
DK
1998
1999,
1999
CPMP
2000
ςη ώνγ ησοδκέ νητ όπα νιρπ ςιεσρύσοπΑ ήκιτηνρΑ
s Assessment phase s Decision Process
αίψηφοιελπ άτακ ήκιτεΘ
s EMEA post-opinion phase s Company stop-clock
ήκιτεθ ανωφό Ο
Centralised procedures
2000
CPMP opinions on initial applications in the centralised procedure 1995-2000
1999
35
1998
30
1997
25
1996
20
1995
15
0 5 10 15 20 25 30 35
10
οδοίρεπ νητ άτακ αίσακιδαιδ 1995 - 2000
1995
CPMP
1996
30/ 97
1997
1998
2000
0 2 4 6 8 10 12 14
10
V:
5
M:
0
H:
B
C:
DK D
S:
E
L:
L E
όκιτηιοπορυο οκιτηννεΓ, -
F
G:
IRL
αίγολοτα ιΑ
I
B:
S I L
N:
NL N
J:
A
D:
P
ςό σιλοβατεΜ
FIN S
A:
UK
2000
s Rapporteur
1999
s Co-rapporteur
1998
There has been a significant increase in the number of opinions in 2000 for medicinal products falling in the metabolism (class A) and antineoplastic – immuno-modulating (class L) anatomical therapeutic chemical (ATC) classification codes.
1997
The highest number of withdrawals from the centralised procedure continue to fall within the ATC categories of blood (class B), neurology (class N) and oncology (class L).
1996
CPMP opinions by therapeutic class 1995-2000
1995
s 2000 45 s 1999 s 1998 40 s 1997 35 s 1996 s 1995 30
B
25
A
20
0 5
15
10 15 20 25 30 35 40 45 1995 - 2000
10
L).
5
()
0
()
A
(
B
),
C
(,
D
, (,
G
,
H
L)
L
(
N
,
S
,
V
οΤ
A:
2000,
Metabolism B:
31/ 97
Blood C:
αδίλεΣ
Cardiovascular
ησεθκέ αισήτΕ 2000
Dermatologicals G:
EMEA/ MB/ 050/ 00
Genito-Urinary, sex hormones H:
FUM - SO
Endocrinology
PSUR
J:
ΕΕ νητσ
Musculo Skeletal
ADR
N:
ΕΕ ςότκε
27 EMEA General Report 2000
ADR
Withdrawal of applications in the centralised procedure 1995-2000
2000
14
1999
12
1998
10
1997
8
1996
6
1995
4
1995 1996 1997 1998 1999 2000
2
50
0
1995 - 2000
1995
500
1996
16000
1997
1997
250
1996
237
1995
200
7
27
5
66
0 1
164
15 66
15
16 27
16
50
5
164 311
7
102 237
1995
158
1996
109
1997
100 150 200 250 300 350
1998
οδοίρεπ νητ άτακ ςαίσακιδαιδ 1995 - 2000 ςήκιρτνεκ ςητ οισίαλπ οτσ ανέ ιρκεκγε ατνόϊορπ άκιτυεκα ραφ αιγ ςιεσάτκεπε ιακ ςιεσήιοποπορτ ε άκιτεχσ ςε ώνΓ ΑΕΜΕ νοτ όπα ιατνονώιαρεπκειδ υοπ
1999
.
2000
αιελάφσα
Extensions
νητ ε άκιτεχσ ςησωρέ ηνε (PSUR)
Type II variations
νωεσέθκε νώκιδοιρεπ νωτ ιακ
Type I variations
νωκά
28 EMEA General Report 2000
ραφ ςειεγρένε ςετη ύθιπενα ςενε ύογολοναθιπ (ADR)
EU and non-EU adverse drug reports 1995-2000
νασύοροφα υοπ νωεσέθκε νωτ ςό θιρα ο ιενάξυα αν εσηθύολοκαξε
16000
οτ αρετόκιδιΕ ςαίσακιδαιδ 2000,,
14000
.
12000
ςήκιρτνεκ ςητ οισίαλπ οτσ νωνέ ιρκεκγε νωτ νωτνόϊορπ νώκιτυεκα ραφ νωτ ύο θιρα ύοκιλονυσ υοτ ησηξύα νητ ιεζίρτποτακιτνα
10000
οτ άτακ ησηνπύργαπεοκα ραφ ητ ιακ ςιεσήιοποπορτ ςιτ ςωίδι 2000,,
8000
, ςαίεδα ςησηγήροχ ςητ ιατνοπέ υοπ ςετητόιρητσαρδ ςιτσ άροφα νοσό ςαίσαγρε υοτρόφ υοτ ησηξύα Η
6000
2. 2
4000
32/ 97
2000
αδίλεΣ
0
ησεθκέ αισήτΕ 2000
1995
EMEA/ MB/ 050/ 00
1996
2000
1997
νακηθώρηλκολΟ
1998
νακηθώρυκιπΕ 1999
1999
ςιεσήιοποτσωνΓ
2000
1998
s Non-EU ADRs
104
s EU ADRs
160
Period safety update reports, follow-up measures and specific obligations 1995-2000
308
500
33 72 82
400
7
300
7
200
50 100 150 200 250 300 350
100
1998 - 2000
1998
2000,
1999
,
2000
CPMP.
s PSURs
CPMP,
s FUM - SO
ςητ ςαιελέ ολο ςητ νωεσάιρδενυσ νωτ ιατίεγηορπ υοπ αρέτυε∆ ητ ανή εθάκ ιεζάιρδενυσ αδά ο Η, ΑΕΜΕ υοτ ιακ ςήπορτιπΕ ςήκϊαπωρυΕ ςητ νώλε νώταρκ νωτ ςυοπώσορπκε
Work continued on the development of EudraVigilance, the electronic Community pharmacovigilance system for transmission and management of adverse drug reactions.
όπα ιατίελετοπα αίοπο η ςαδά ο ςητ ιατατσΐορπ ΑΕΜΕ υοτ ςοπωσόρπκ ςαίσακιδαιδ ςήκιρτνεκ
A joint pilot for the implementation of the electronic transmission of individual case safety reports was initiated and five meetings were held at the EMEA with participants from 7 national competent authorities and 17 pharmaceutical companies.
ςητ οισίαλπ οτσ ιατνολλάβοπυ υοπ ςιεσήτια όπα νυοτπύκορπ ιακ ςείσα ονο ςέκιροπ ε ςιτσ νύοροφα υοπ ατα ήτηζ ε άκιτεχσ υογόλαιδ α ήβ ςω ιεσήγρυοτιελ αν υονέ ιεκορπ νώισα ονο νώκιροπ ε
The new EudraVigilance Technical Implementation Group was established in 2000, under the aegis of the European Commission Telematic Steering Committee, comprising representatives of the Commission, Member States and EMEA.
ςητ ςοτα ήτια νιπόταΚ 2000 CPMP,
The Group is chaired by the EMEA and met twice in 2000.
ΑΕΜΕ υοτ αίρδεορπ
29 EMEA General Report 2000
νητ όπυ
Regulatory affairs
οτ άτακ
Tradenames
ςέροφ ούδ εσαίρδενυσ ήπορτιπε Η ΑΕΜΕ υοτ ιακ νώλε νώταρκ νωτ ςήπορτιπΕ ςητ ιοπωσόρπκε
An ad hoc Tradename review group was set up in 2000 at the request of the CPMP as a forum for the discussion of tradename-related issues arising from centralised applications.
νυοχέτε υσ αίοπο νητσ ςήπορτιπΕ ςήκϊαπωρυΕ ςητ ςήκιτα ελητ ςήπορτιπε ςήκιτσινοτνυσ,
The group is chaired by an EMEA representative and is composed of Member States representatives, the European Commission and EMEA representatives.
ςήγο ραφε ςήκινχετ αδά ο αέν η εκηθάτσυσ
The group meets every month on the Monday prior to the CPMP plenary meetings for the review of objections and comments made by Member States, Iceland and Norway, with a view to making recommendations to the CPMP.
EudraVigilance
Parallel distribution
ΑΕΜΕ υοτ ςιεσάτσατακγε ςιτσ ςιεσάιρδενυσ ετνέπ νακηθώναγροιδ ώνε ςιεσώτπιρεπ ςενέ ωνο ε
The workload for parallel distribution notifications increased significantly in 2000, greatly in excess of the level foreseen in the Work Programme 1999-2000.
νύοροφα υοπ αιελάφσα νητ ε άκιτεχσ νωεσέθκε ςησαβίβαιδ ςήκινορτκελη ςητ ήγο ραφε
The main destination for products being primarily Germany and the UK, whilst the main Member States of origin were Spain, France, Italy and Austria.
ύοκιτονιοκ υοτ
Parallel distribution notifications 1998-2000
ησεθκέ αισήτΕ 2000
350 308 300 s Notifications
EMEA/ MB/ 050/ 00
250 200 150
ατητόιοΠ
s Validated s Finalised
CPMP
160
οΤ
104
2000
100
26
82
3
72
196
50 0
60
7
35
7 0
20
33
1995 -
1998
ςέλυοβ υσ ςέκινο ητσιπΕ
2000
ο λονύΣ
1995-2000
ςέλυοβ υσ ςέκινο ητσιπΕ
Scientific advice given
2. 3
20
34/ 97
35
.
60
66
58
ωγόλ νε ο
196
ιεσάβ ιατνογέλιπε
Follow-up to scientific advice
ιοίοπο ιο νώιενεθσα νωίναπσ ατα έθ εσ ςύοκιδιε ςενο ώνγοριεπ ε όπα ιατνύορυοκιπε ςέτσινοτνυσ
3
,
8
,
4
-- 26 3
26
71
30 EMEA General Report 2000
29
The process also benefited from an increase in the time available for interaction between applicants and the experts involved in the procedures during CPMP week.
2000
Of the 7 negative opinions/ withdrawn applications, 1 had received scientific advice prior to the application.
ήπορτιπε
Distribution of scientific advice requests in 2000
ςησητία
Quality 7%
νητ όπα
Biotechnology 10%
ςήλοβοπυ
Clinical development 62%
νακηθίρκγε
Pre-clinical development 21%
COMP COMP
The COMP in 2000
νακηθίρκγε COMP COMP ν
Chairman of the COMP Vice-chairman of the COMP
ςησεθόρπ
Josep TORRENT i FARNELL Yann LE CAM
ςητ ςε ώνγ ςητ ςε ώνγ
Details of membership of the Committee can be found in Annex 6.
ακηθρύσοπα νακηθήλβοπυ
1) and Commission Regulation (EC) No 847/ 2000 of 27 April 2000 (OJ L 103, 28.4.2000, p.
ςητ η
5)).
ιροιδσορΠ -
Incentives include a 10-year period of market exclusivity, protocol assistance from the EMEA and the possibility of fee reductions for all activities relating to the centralised marketing authorisation procedure.
ςέκιτηνρΑ
31 EMEA General Report 2000
ςέκιτεΘ
The Committee met eight times in 2000 to review applications for designation and the development of guidance documents.
υοπ ςιεσήτιΑ υοπ ςιεσήτιΑ σηίοποτσωνΓ ςοτΈ ςύογηροχ ςυοτ ιε άρδνυσ.
The COMP is the first institutional committee of the European Union to have patient organisation representatives as full members.
αν υονέ ιεκορπ ςησητία ςητ ήλοβοπυ νητ όπα νιρπ ςιεσάιρδενυσ εσωνάγροιδ ΑΕΜΕ Ο
Josep Torrent i Farnell and Yann Le Cam were elected chairman and vice-chairman respectively, for a term of three years renewable once.
υοτ
Applications for orphan designation
25
The EMEA held 25 pre-submission meetings to assist sponsors.
2000.
Year
ραφ νώναφρο ό
Intent to file notified
σιροιδσορπ νοτ αιγ ςιεσήτιΑ
Applications Applications submitted withdrawn
COMP
Positive COMP opinions
ακα ράφ άναφρο ατ αιγ ήπορτιπε αέν Η (COMP),
Negative COMP opinions
5).
Designations granted by the Commission
ΕΕ
2000
.
71
()
3
1)
26
141/ 2000 (
-
(
8
ακα ράφ άναφρο ατ αιγ υοίσιαλπ ύοκιτεθο ον υοτ
A coordinator from the EMEA and from the COMP is appointed for each application for designation.
οτ ςούχσι ςηξρανέ ςητ οθυολόκα νατή ότυΑ 2000,,
They are assisted by experts on rare diseases drawn from a list nominated by the Committee.
υοτ οιλίρπΑ νοΤ
The list had 66 experts at the end of 2000.
α ητράραπ οτσ ιατνοχέραπ ςήπορτιπε ςητ ηλέ ατ ε άκιτεχσ αίεχιοτσ ήρε οτπεΛ
The highest number of applications for orphan medicinal product designation by therapeutic class in 2000 was in the antineoplastic and immuno-modulating area (class L).
ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ αίγρυοτιεΛ
Applications for orphan medicinal product designation by therapeutic class 2000
Ν
25
Ο
20
άΜ
15
0 10 20 30 40 50 60 70
10
.
5
N
0
L
A
H
B
H:
H
A
J
B:
L
N:
N
C:
R
A:
A:
οτ νακηθήλβοπυ
Blood
2000
C:
EMEA/ MB/ 050/ 00
Cardiovascular H:
ιεξίλεξε
Endocrinology
υοίλυοβ υΣ
Antiinfective L:
ςαίγηδο ςητ 75/ 319 /
Antineoplastic – immuno-modulating
ηνί αρτυοπ ιΣ
Nervous System R:
16. 11. 2000
Respiratory
υοίλυοβ υΣ
32 EMEA General Report 2000
υοτ ΚΟΕ
Applications and opinions for orphan medicine designation 2000
11
70
Capthydro
60
νε αίσακιδαι∆
Applications per month Cumulative opinions
υοτ ΚΟΕ
50
ςαίγηδο ςητ 75/ 319 /
Cumulative applications
Ketoprofen Retard Scand Pharm
40
29. 06. 2000
30
ορθρΆ
20
ιεξίλεξε
0 April
ςήπορτιπΕ ςητ
May
541/ 95
June
Cerazette
July
νε αίσακιδαι∆
August
θιρα ΚΕ ύο σινονακ υοτ.
September
Zofenopril
October
ςητ ςη
November
27. 07. 2000 ώνγ
Details are given in Annex 10.
ςοφαργάραπ ορθρΆ 5
2.5 Working party activities
7,
Details of notes for guidance, points to consider documents and position papers prepared by the working parties for the CPMP are given in Annex 11.
CPMP
Working Party
ςαίσακιδαιδ
Chairperson
(INN)
Meetings in 2000
αίσα ονο ςήνθειδ ητσηρχόνιοΚ ςήκιλετ αίνη ορε Η
consider documents approved in 2000
ςήκιτπ επαραπ ςοδίΕ
Pharmacovigilance working party (PhVWP)
ουτκίδαι∆ οτσ ΑΕΜΕ υοτ ησέθ ητσ ιατνούεισο ηδ ςείσακιδαιδ ςενέ ωρηλκολο ςιτ ε άκιτεχσ. ςείροφορηλΠ νακηθώρηλκολο ςείοπο ςιτ όπα ςείσακιδαιδ ςέκιτπ επαραπ νακηθήνικ
Patrick WALLER
.
8
,
Biotechnology working party (BWP)
οΤ
Giuseppe VICARI, then Jean-Hughes TROUVIN
2000
5
αίσαγρενυΣ αιεχένυσ ητσ
Scientific advice review group (SARG)
υορδέορπ ηέρχ νώλετκΕ
Mary TEELING, then Markku TOIVONEN
ατητόκιτα σελετοπα
Blood and plasma working group (BPWG)
Alfred HILDEBRANDT,
Manfred HAASE
Manfred HAASE TOIVONEN
Safety working party (SWP)
ατ αιγ ςαίσαγρε αδά Ο
Beatriz SILVA LIMA*
(SARG)
3
Markku
1
αιεχένυσ ητσ ιακ
Efficacy working party (EWP)
νώλυοβ υσ νώκινο ητσιπε
Alfred HILDEBRANDT, then Barbara VAN ZWIETEN-BOOT*
9
*
Giuseppe VICARI,
Acting Chairperson
Patrick WALLER
33 EMEA General Report 2000
ητ αιγ ςαίσαγρε αδά Ο
2.6 Cooperation with competent authorities
2000 οτ νακηθίρκγε υοπ ησατέξε ςορπ
Referrals and arbitrations
2000 νωίε ησ αφαργγέ ιακ ςέ αργ ςειρήτνυθυεταΚ
There were 9 referral procedures in 2000, of which 5 were finalised.
άτακ ςιεσ άιρδενυΣ -
Information on finalised procedures are published on the EMEA web site.
ςορδεόρΠ
Type of referral
ςαίσαγρε αδά Ο
Date of CPMP final opinion
11. α ητράραπ οτσ ιατνοχέραπ
International non-proprietary name (INN)
νητ αιγ ςαίσαγρε ςεδά ο ςιτ όπα νακηθχάτνυσ ιατεζίρητσοπυ CPMP
Article 7(5) Commission Regulation EC 541/ 95 Article 10 Council Directive 75/ 319/ EEC Article 11 Council Directive 75/ 319/ EEC
άκιτηγηδοθακ ε άκιτεχσ αίεχιοτσ ήρε οτπεΛ
27.07.2000 Procedure ongoing 29.06.2000 Procedure ongoing 19.10.2000
οτ άτακ άκιτκατ νασαίρδενυσ οιαλάφεκ 2000.
Zofenopril Cerazette Ketoprofen Retard Scand Pharm Capthydro Glucophage
επέλβ ατητόιοπ νητ αιγ
Article 12, Council Directive 75/ 319/ EEC
ςαίσαγρε αδά ο ήνιοκ η ιακ
16.11.2000 Procedure ongoing Procedure ongoing
19. 10. 2000 ιεξίλεξε
Sibutramin Calcitonins Cisapride
ςαίγηδο 15,
Article 15, Council Directive 75/ 319/ EEC
ςητ ορθρΆ
19.10.2000
Cisapride
Sertindole
νε αίσακιδαι∆
International Conference on Harmonisation
αργ ςειρήτνυθυετακ ςέκιλεΤ
International Conference on Harmonisation (ICH)
Choice of control group in clinical trials (CPMP/ ICH/ 364/ 96), ICH E10 Clinical investigation of medicinal products in children (CPMP/ ICH/ 2711/ 99), ICH E11 Safety pharmacology studies for human pharmaceuticals (CPMP/ ICH/ 539/ 00), ICH S7A Stability testing guidelines: stability testing of new active substances and medicinal products (CPMP/ ICH/ 2736/ 99 rev. of CPMP/ ICH/ 380/ 95), ICH Q1AR Non- clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ ICH/ 286/ 95, modification), ICH M3 modification Reproductive toxicology: toxicity to male fertility (CPMP/ ICH/ 136/ 95 modification), ICH S5B modification Data elements for transmission of individual case safety reports (CPMP/ ICH/ 287/ 95 modification), ICH E2B Recommendations on electronic transmission of individual case safety reports message specification (CPMP/ ICH/ 285/ 95), ICH M2 Good Manufacturing practice guide for active pharmaceutical ingredients (CPMP/ ICH/ 4106/ 00), ICH Q7A Common Technical Document (CTD), (CPMP/ ICH/ 2887/ 99), ICH M4
Final guidelines • Choice of control group in clinical trials (CPMP/ ICH/ 364/ 96), ICH E10 • Clinical investigation of medicinal products in children (CPMP/ ICH/ 2711/ 99), ICH E11 • Safety pharmacology studies for human pharmaceuticals (CPMP/ ICH/ 539/ 00), ICH S7A • Stability testing guidelines: stability testing of new active substances and medicinal products (CPMP/ ICH/ 2736/ 99 rev. of CPMP/ ICH/ 380/ 95), ICH Q1AR • Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ ICH/ 286/ 95, modification), ICH M3 modification • Reproductive toxicology: toxicity to male fertility (CPMP/ ICH/ 136/ 95 modification), ICH S5B modification • Data elements for transmission of individual case safety reports (CPMP/ ICH/ 287/ 95 modification), ICH E2B • Recommendations on electronic transmission of individual case safety reports message specification (CPMP/ ICH/ 285/ 95), ICH M2 • Good Manufacturing practice guide for active pharmaceutical ingredients (CPMP/ ICH/ 4106/ 00), ICH Q7A • Common Technical Document (CTD), (CPMP/ ICH/ 2887/ 99), ICH M4
αργ ςειρήτνυθυεταΚ
34 EMEA General Report 2000
Bracketing and matrixing designs for stability testing of drug substances and drug products (CPMP/ ICH/ 4104/ 00), ICH Q1D Maintenance of the guideline on impurities: residual solvents: permissible daily exposure (PDE) for Tetrahydrofuran and N. Methylpyrrolidine (CPMP/ ICH/ 283/ 95), ICH Q3C( M)
Guidelines released for consultation • Bracketing and matrixing designs for stability testing of drug substances and drug products (CPMP/ ICH/ 4104/ 00), ICH Q1D • Maintenance of the guideline on impurities: residual solvents: permissible daily exposure
CVMP
(PDE) for T
οτσ ιατνεθίταραπ
etrahydrofuran and N. Methylpyrrolidine (CPMP/ ICH/ 283/ 95), ICH Q3C(M)
EMEA/ MB/ 050/ 00 2000 ησεθκέ αισήτΕ
Details of these and other CVMP guidelines are given in Annex 11.
αδίλεΣ
Working Party on Herbal Medicinal Products
ησεθκέ αισήτΕ 2000
The Working Party on Herbal Medicinal Products met at the EMEA on 3 occasions in 2000, chaired by Konstantin Keller.
EMEA/ MB/ 050/ 00 ατνόϊορπ άκιτυεκα ραφ άκιτυφ νύοροφα υοπ ατα ήτηζ ε άκιτεχσ όνιοκ. οτ ε ςαίσαγρε ςαδά ο ςητ αίνωνιοκιπε νητσ ςαιενάφαιδ ςητ ησωίτλεβ ητ αιγ ςιεσάτορπ ιακ υογόλαιδ υοτ ςήγο ραφε οίδεπ οτ νατνονάβ αλιρεπ νακηθήτηζυσ υοπ ατα έθ ατΣ ςιεσώνε ςέκϊαπωρυε.
A position paper was prepared in collaboration with CPMP pharmacovigilance and safety working parties and published in November 2000.
ςενε όρεφαιδνε ναχίετε υσ
Details of notes for guidance and position papers from the group are given in Annex 11.
αίοπο νητσ ησαίρδενυσ εκηθώναγροιδ α ητράραπ οτσ ιατνεθίταραπ αδά ο νητ όπα 11.,
Topics discussed included the scope of dialogue and proposals for improved transparency in the communication from the working party to the public on herbal related matters.
2000υοτ οιρβώτκΟ νοΤ νακηθχάτνυσ αίοπο
2.7 Activities of the mutual recognition facilitation group
ατ ιατεζίρητσοπυ υοπ ησέθ ητ ε αφαργγέ ιακ ατα ήν οπυ άκιτηγηδοθακ ε άκιτεχσ ςειερέ οτπεΛ, υοτ οιρβ έοΝ νοτ εκηθύεισο ηδ οίοπο οτ ιατεζίρητσοπυ υοπ
The 11 meetings of the group were chaired by António Melo Gouveia during the Portuguese Presidency in the first half of 2000 and Jean-Michel Alexandre during the French Presidency in the second half.
ησέθ ητ ε οφαργγέ εκηθχάτνυσ αιελάφσα νητ ιακ ησηνπύργαπεοκα ραφ νητ αιγ
Two informal meetings of the MRFG were organised under the presidencies to discuss issues related to the mutual recognition procedure such as transparency, quality of assessments and the 2001 review were discussed.