Principles and Practice of Pharmaceutical Medicine

Centralized procedure

Inthe centralized procedure, productsfalling within
AnnexAhavetobeprocessedbythisroute,products

in Annex B may be processed by this route at the

discretion of the manufacturer. Applicants using the

centralized procedure may nominate a member of

the CPMP to act as rapporteur and co-rapporteur.

However, the final choice of rapporteur and co-

rapporteur remains within the remit of the CPMP.

ThemembershipoftheCPMPhasbeenmadesothat

it is now a technically expert committee which

advises the EMEA. The opinions of the CPMP are

referredtomemberstates,whohaveaperiodoftime

to comment back to the CPMP. Thereafter, an opi-

nionisissuedwhichisbindingonthememberstates.

Tables 33.5 and 33.6 show the work of the

EMEA in terms of centralized procedure applica-

tions dealt with since the inception of the current

scheme on 1 January 1995 to 19 December 1999.

Table 33.5 shows the new applications submitted to

the EMEA under the centralized procedure, and

Table 33.6 shows the number of variations to MAs

granted under the centralized procedure. It can be

envisaged that variations are going to comprise the

major part of EMEA’s workload, in the same way

as it does for national drug regulatory authorities.

The MCA (now the MHRA) has remained the

dominant regulatory authority regarding the share

of work conducted under the two revised commu-

nity procedures, for example in March 1996, the

Annual Report of the MCA for 1995/96 states:

‘The MCA was responsible for eight of the 21

mutual recognition procedures that had been suc-

cessfully completed (38%) and was the reference

member state for 10 of the 23 procedures in pro-

gress at that date’. The United Kingdom was also

the rapporteur or co-rapporteur for 19 of 81 appli-

cations made to the centralized procedure in 1997

(European Agency for the Evaluation of Medicinal

Products, Third General Report 1997). The distri-

bution of work on centralized applications by the

member state is shown in Table 33.7. The proces-

sing times for centralized applications is shown in

Table 33.8.

Decentralized or mutual recognition

procedure

Table 33.9 shows the use of the ‘decentralized’ or

‘multistate’ or ‘mutual recognition’ procedure

Pre-submission phase

Rapporteur/Co-rapporteur appointed

Centralised Procedure starts

(Day 0)

Rapporteur and Co-rapproteur

assessment reports circulated on

Day 70 of procedure

Comments from other Members

of CHMP by Day 100

CHMP agrees consolidated list of

questions to applicant by Day 120

Joint assessment of responses by Rapporteur

and Co-rapporteur within 30 days

(Day 150 of procedure)

CHMP decides whether a hearing is

required on outstanding issues

(Day 180 of procedure)

CHMP final opinion (Day 210)

Commission Decision after 30 days

Community authorisation

Applicant responds

within 6 months

Figure 33.1 Centralized procedure for biotech (man-
datory) and high-tech (optional) medicines (from
1 January 1995).Source: Griffin and O’Grady (2006)

434 CH33 THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE