Photography: Comstock, Photodisc Illustration: Paul A. Belci
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For pharmaceutical and biotech companies wishing to operate on an international basis, a clear understanding of the different
regulatory requirements across countries is critical. With the regulatory requirements constantly changing in different countries,
however, keeping up to date is no easy matter. An important development in the European Union (EU) has been the adoption of
the new EU Clinical Trials Directive (2001/20/EC),1 which will affect all companies wishing to undertake clinical trials within the EU and has thus attracted considerable attention.
The two primary objectives of this directive are to provide a more harmonized and structured European regulatory framework,
and to ensure the safety of patients enrolled in clinical research.
Pharmaceutical industry in Portugal Since its accession to the EU in 1986, Portugal has played an active role on the European stage, and was one of the first
member countries to adopt the Euro currency in 1999. The pharmaceutical industry is considered a key sector by the Portuguese
government, and in 2002, it publicly announced its desire to stimulate domestic industrial growth while encouraging international
companies to base their businesses there.2 Around 130 pharmaceutical companies operate in Portugal and employ nearly 11,000 people.3 Health- care spending has nearly doubled since 1995, and the country has become an important pharmaceutical market.3 The emphasis on health care has also seen Portugal grow in importance as a center of clinical research, as pharmaceutical
companies encourage physicians to gain more experience with their products.
The steady growth in clinical research is certain to be enhanced by Portugal's ongoing implementation of the Clinical Trial
Directive legislation, which will ultimately streamline the submission approval process and running of clinical studies in
the country, and significantly improve timelines to competitive levels.
Unlike the outgoing system in which ethical approval is obtained followed by regulatory notification, the new law establishes
the necessity of obtaining authorization from both the Competent Authority (INFARMED)4 and ethics committee (EC) in order to conduct a clinical trial. Such authorizations can be submitted in parallel. Transition period The directive made provisions for a two-year transition period in order for it to be incorporated into national law, and one
further year (until 1 May 2004) for final implementation. However, in Portugal as with some other EU member states, the directive
timelines were somewhat protracted.
The legal text of the directive was implemented into the national legislation (Lei No. 46/ 2004) back in August 2004. However,
the required guidelines for procedures have yet to be introduced, including the establishment of necessary regulatory and
ethics infrastructures in order to apply the principles set out in the new law. Until recently, INFARMED implemented a transition
period whereby clinical trial applications were submitted in a hybrid format. Now, INFARMED is receiving CTAs for full review,
rather than notification. The transition period essentially involved following the current procedure of initially seeking
ethics approval and then notifying INFARMED of the authorization together with a submission of the essential documents (including
the EudraCT application form) as stipulated in the national EudraCT checklist. Incidentally, during this transition period,
no additional national documents were required.
EudraCT, established in keeping with the European Directive, is a database of all interventional clinical trials of investigational
medicinal products in the EU (registered after 1 May 2004), which records submissions made to both the Competent Authority
and the EC. Sponsor entry can be made via the EudraCT Web site5 for the purposes of obtaining the necessary EudraCT identification number, gaining access to supporting documentation such
as directives and guidelines, and for completing, saving, and printing electronic forms relating to clinical trial applications,
amendments, and end-of-trial notifications.
Regarding this transition period, INFARMED published a circular (September 2004) declaring that if at least one ethics approval
for a clinical trial was obtained before the implementation of the new procedures, that clinical trial would ultimately follow
the current transitional system. One important requirement, article 4.1, is that the sponsor must register the clinical trial
in the European Database6 and consequently obtain a EUDRACT number unique to that study.
