UCB SA - BNP Paribas Fortis

supervision and control by various regulatory authorities and its production activities must comply with
applicable health, safety and environmental regulations.
Relevant regulations are typically of a national scope, although within the EU a considerable degree of
harmonization exists. The EU institutions have created a common regulatory framework that applies in
every EU member state (and that sometimes allows EU member states to adopt more detailed and more
stringent regulations), and has indirect harmonizing effects in certain other European countries. Review
and approval of certain products such as those generated at the Issuer is handled by the EMEA in a
centralised procedure which, in the event of a positive outcome, results in approval for the product in all
EU countries. In the United States such regulatory review is handled by the FDA.
(a) Product approval
Before the UCB Group can market pharmaceutical products in a particular country, it is required to
obtain regulatory approval in accordance with the applicable national regulations. Following receipt of
initial marketing approval, regulatory approval must be maintained in order to continue to market
products. The regulatory requirements follow stringent standards that vary by country. From drug
discovery through pre-clinical development and clinical trials to approval and initial product launch, the
process of developing a pharmaceutical product is intensive, lengthy and rigorous, and takes
approximately ten years. This period varies considerably depending on the targeted therapeutic area.
Regulatory authorities have the right to link their approval to the implementation of stringent risk
management measures for each drug which go beyond standard pharmacovigilance procedures. These
measures may include additional clinical studies which can add substantially to the investment required
to develop a new drug and to obtain and maintain its regulatory approval.
Development of New Products
Once a new compound has been identified in the laboratory as a potential candidate drug through a
screening process, it undergoes broad pre-clinical testing. During pre-clinical testing, in-vitro tests and
other studies in tissues and animals are conducted to show biological activity of the compound in
models of the targeted disease, as well as to evaluate its potential toxicity. These steps are generally
undertaken by UCB NewMedicines.
To begin clinical trials (i.e., tests of the drug in humans) in the EU, applications have to be filed with the
regulatory authorities of each member state in which clinical trials are intended to take place. To begin
clinical trials in the United States, an investigational new drug (“IND”) application is filed with the
FDA. The IND becomes effective if the FDA does not reject it within 30 days from its filing. In other
countries there are varying but similar requirements before beginning clinical trials.
Clinical testing prior to filing for a marketing license is usually done in three phases. This clinical
development program can eventually be followed by a Phase IV study programme which is performed
after marketing approval has been obtained. The size and the duration of clinical trials depend very
much on the targeted disease. Typically, several hundred to several thousand patients have to be treated
successfully under the highly controlled conditions of clinical trials before a sponsoring pharmaceutical
company can apply for marketing authorisation. The duration of trials and the vast amount of data that
must be collected and evaluated makes clinical testing the most time-consuming and expensive part of
new drug development.
Marketing Approval for New Products
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