Principles and Practice of Pharmaceutical Medicine

[COM(97) 183 Fund], the European Commission
emphasized thathigh-quality scientific committees
are an essential foundation for EC rules in this area.
It was decided in August 1997 that DG XXIV
Consumer Policy and Consumer Health, now
renamed the Health Directorate in 1999 Protec-
tion, should set up a number of eight new
advisory committees, including a Scientific
Committee on Medicinal Products and Medical
Devices. These committees are expected to meet
10 times per year, and the Committee on Medic-
inal Products and Medical Devices met for the
first time on 10–14 November 1997. TheEur-
opean Drug and Device Reportstated: Feathers

are understood to be ruffled in the EU’s Commit-

tee for Proprietary Medicinal Products; however,

up to now, the CPMP has largely held a mono-

poly on scientific opinion.

The Commission said the new Scientific Committee

will not overlap CPMP and there does appear to be a

role for both panels.

Unlike the CPMP its minutes would be public.

Drug companies have feared that the committee

would lean more toward consumers than industry.

The interaction between CPMP (which reports

to the Enterprise Directorate, formerly the Com-

missions DG III Industry Affairs) and the new

Medical Products and Medical Devices Commit-

tee, which reports to the Health Directorate,

formerly DG XXIV Consumer Policy, is very

uncertain. It has to be borne in mind that the

objective of Directive 65/65 was to advance the

Table 33.7 Distribution of work on centralized
procedure applications among EC member states

Country Number of times a country has
been rapporteur or co-rapporteur

Belgium 17
Denmark 25
Germany 34
Greece 2
Spain 19
France 37
Ireland 25
Italy 18
Luxembourg 6
The Netherlands 33
Austria 12
Portugal 12
Finland 15
Sweden 36
UKa 36

aUK has been rapporteur for 21 applications.

Table 33.8 Processing times (days) of centralized applications to EMEA, 1995–1999

Year Assessment Decisions EMEA post-opinion Company Total

phase process phase clockstop

1995 189 45 119 59 412

1997 169 40 79 119 407

1997 178 32 86 139 435

1998 185 42 83 109 419

1999 183 38 70 148 439

Table 33.9 Total number of finalized mutual

recognition procedures by type, August 1995–

December 1997a

Number Percent

New active substance 77 31.5

Generics 45 18.4

Line extensions 29 11.9

Fixed combination 20 8.2

OTC 6 2.6

Herbal 2 0.8

Others 65 26.6

aThe number includes multiple procedures (total¼244).

33.4 THE EUROPEAN CONTROLS OF MEDICINAL PRODUCTS 437