UCB SA - BNP Paribas Fortis

Before a drug can qualify for marketing approval, a registration dossier must be submitted to the
regulatory authorities of the jurisdictions where the drug is intended to be marketed. In the EU, the UCB
Group has to follow either the centralized procedure at the EMEA, the mutual recognition procedure,
the decentralized procedure or the national procedure depending on the therapeutic area, type of product
and the number of countries in which the UCB Group intends to market the drug. In the United States,
UCB has to file a new drug application (“NDA”) or biological licence application with the FDA. Other
countries accept variations of the EU or United States registration dossiers, as long as they contain a
specific national chapter in a special format and the native language. The submission of a registration
dossier to a regulatory authority does not guarantee that approval to market the product will be granted.
The registration dossier contains detailed information about the safety, efficacy and quality of a new
medication. It also provides details about the manufacturing process, the production facilities and
information to be provided to patients and medical practitioners.
The registration process can last from a few months to a few years and depends on the nature of the
drug under review, the quality of the submitted data, the registration procedure, the medical needs, the
efficiency of the relevant agency and the jurisdiction in which the application is filed.
In the EU, the authorities have to decide on marketing approval within 210 days following receipt of a
complete marketing application. For products to be approved under the centralized procedure at the
EMEA, the time period may be reduced to 150 days. These time periods do not include delays during
which the sponsoring company has to respond to numerous detailed questions regarding the product
raised by the authorities.
In the United States, the FDA is required to review and provide a Complete Response Letter within 10
months of filing the registration dossier. The Complete Response Letter will notify the company of the
additional information required by the FDA in order for it to provide approval. Alternatively, approval
may be granted in the Complete Response Letter. For drugs designated as ‘‘priority’’ drugs, the
maximum review time for the FDA is six months.
In recent years, the EMEA, FDA and the Japanese Ministry of Health, Labour and Welfare have sought
to shorten development and registration periods for pharmaceutical products by harmonizing the
individual requirements of the three regions through the work of the International Conference on
Harmonization (“ICH”). The implementation of the requirements which have been resolved by the ICH
would not completely harmonize the regulatory processes in the United States, Japan and the European
Union. The UCB Group would still need to address region-specific development requirements to obtain
marketing approval in these three regions.
Once the EMEA, the FDA or the regulatory agency in another country have approved the marketing
application, the new pharmaceutical drug becomes available for sale. The marketing authorization may
be granted for an unlimited term or be subject to renewal. In the European Union marketing approval is
granted for an initial period of five years. Following the expiration of this five year period, the EMEA
will decide whether to renew the marketing approval for an indefinite term. In many countries approval
is followed by intense and lengthy submissions to and negotiations with panels such as pricing and
reimbursement authorities, health technology assessment bodies and committees granting approvals to
formularies before the product can be made available for sale.
Pharmacovigilance
The UCB Group performs high-quality clinical safety and pharmacovigilance activities for drugs under
development and marketed drugs. These surveillance and reporting processes are highly regulated with
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