Abstract
A review of preclinical assessment reports on immuno-modulatory biopharmaceuticals submitted to the Eur-opean Agency for Evaluation of Medicinal Products from 1995 to the middle of 1999 was conducted. Questions regarding the rationale for the preclinical development programmes were often put to the applicants. Effects mediated via changes of the immune function, including risks of reproductive toxicity and tumorigenicity, were of Background: European Union regulatory review process In 1995, the “New System” for authorisation of medicinal products in the European Union (EU) was introduced. At the same time, the European Agency for Evaluation of Medicinal Products (EMEA) was created. The EMEA is the permanent secretariat for the Committee for Proprietary Medicinal Products (CPMP), which is a scientific committee responsible for human medicinal products. Since 1995, it has been possible to submit a single EU marketing authorisation application (MAA) to the EMEA, which is reviewed following a predefined procedure with set time frames. The CPMP has two representatives from each member state and for each MAA, a rapporteur and a co-rapporteur are assigned from this represen-tation. The primary evaluation is performed by assessor teams, consisting of European experts from the national agencies and academia, who are engaged by the rapporteurs. These evaluations are subse-quently commented on by experts from the other member states. Within 120 days of active review time, the CPMP agrees on a “List of Questions,” which is sent to the applicant. The applicant's responses to the “List of Questions” are assessed by both rapporteur teams, and their joint *Correspondence: Dr U Liminga, Medical Products Agency, Box 26, S-751 03, Uppsala, Sweden particular concern. This review indicates the need to further develop methods for safety testing of immunomo-dulatory biopharmaceuticals.