Principles and Practice of Pharmaceutical Medicine

interpretation at the national level a necessity for
the expedient approval of any clinical trial project
or program.
Even insurance practices exhibit cross-cultural
differences. The EU guidelines for patient protec-
tion lay down that there should be ‘sufficient’
insurance provision. However, some countries
have taken this requirement a step further by laying
down the actual sums for which individual patients,
or, in the case of Germany, the total number of
patients, must be covered. In the United States,
patients and volunteers are in general insured by
the institution in which the study is conducted; the
fees for this are not directly reimbursed by the
sponsor but form part of the overall study cost.
Apart from the administrative burdens and the
financial implications of insurance, timing of the
approval process is of the essence. There are wide
variations from country to country, which depend
not only on the approval times from the competent
authorities but also on the ethical committee
approval times.
The IND application system in the United States
is often seen as more problematic for companies
than the EU system. However, if the United
States is a potential market for the product under
investigation, there can be significant advantages

to conducting studies under an IND, in parallel

perhaps with other studies in Europe. An IND

application is required in the United States before

any new medicinal product may be introduced into

humans, or before any established product is used

in an experimental or novel way. This applies not

only to a commercial sponsor but also to an inde-

pendent physician wishing to conduct experimen-

tal therapy for his/her own purposes. In the United

States, an IND application must be accompanied

by a completed form FDA 1571, which consists of

a number of sections:

Table of contents

Introductory statement

General investigational plan

Clinical investigator’s brochure

Protocol(s):

• Study protocol


• Facilities data


• Investigator data


• Ethical committee data

Table 50.2 European requirements for submissions to competent authorities to obtain

clearance for initiation of clinical trials

Protocol and supporting EC (IRB) Insurance

documents approval certificate

Austria 

Belgium 

Denmark 

Finland 

France 

Germany 

Greece 

Ireland 

Italy 

The Netherlands 

Norway 

Portugal 

Spain 

Sweden 

UK 

50.2 THE LEGAL/REGULATORY FRAMEWORK FOR DRUG DEVELOPMENT IN EUROPE 649