Principles and Practice of Pharmaceutical Medicine

cover (a) chemistry, pharmacy, manufacturing
route; (b) preclinical aspects, including pharma-
cology, safety pharmacology, pharmacokinetics,
single and repeat-dose toxicological evaluation,
reproduction studies, mutagenic potential and car-
cinogenicity; (c) clinical studies covering phase I–
III studies; ADRs notified to the company during
clinical studies. If the product has been marketed,
then all post-marketing experience should be
assessed. Expert reports are not a promotion plat-
form for the product but an assessment of the data
generated, an explanation of the results and an
interpretation. An expert report should not nor-
mally exceed 25 pages of A4 size. The expert

reports should also make clear whether or not the

studies submitted have been conducted according

to GLP standards and whether the clinical studies

have been conducted to GCP principles and in

accord with the Declaration of Helsinki. A state-

ment of the environmental effects of the product is

also necessary.

DG XXIV Scientific Committee on

medicinal products and medical devices

In a communication to the Council and European

Parliament on ‘Consumer Health and Food Safety’

Table 33.5 Centralized marketing applications to EMEA

Centralized procedures 1997 1998 1999 Total 1995–1999

Applications received

Part A 20 12 18 224

Part B 40 33 29

Withdrawals

Part A 3 8 1 38

Part B 4 12 7

Opinions adopted by product

Part A 6 11 9 133 a

Part B 19 30 17

Opinions adopted by substance

Part A 6 11 8 105 a

Part B 13 19 15

aThese figures include negative opinions given for seven products (representing four substances), and for two

variations.

Table 33.6 Variations and line extensions to marketing applications processed by centralized

procedures

Centralized procedures 1997 1998 1999 Total 1995–1999

Type I variations

Part A 57 50 68 569

Part B 52 108 207

Type II variations

Part A 19 26 48 239 a

Part B 28 40 61

Extension and abridged applications

Part A 32 11 6 73

Part B 2 4 13

aThese figures include negative opinions given for seven products (representing four substances), and for two

variations.

436 CH33 THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE