BRUSSELS, Belgium — The European Agency for the Evaluation of Medicinal Products (EMEA) has unveiled a heavy schedule for its biotechnology working party for the rest of the year.
Among entirely new actions, it is developing a concept paper on cancer vaccines, which will be submitted to the Committee on Proprietary Medicinal Products (CPMP) by December. It also is working on another new concept paper on quality control of cell therapy, for which submission to the CPMP is scheduled in October.
More urgently, it is working with the EMEA's inspection working party on a concept paper on training of inspectors in biotechnology, to be submitted to the CPMP by April.
The program also includes a number of initiatives in the area of CPMP guidelines for pharmaceutical companies developing new biotech products. It is expected to transmit a note for guidance on pharmaceutical and biological aspects of combined vaccines to the CPMP for adoption in July.
By the end of April it has to revise the 1997 CPMP note for guidance on minimizing the risks of transmissible spongiform encephalopathies (TSEs) being passed on via medicinal products, in order to bring the guideline into line with new European Union (EU) legislation in this field.
It will prepare a revised CPMP note for guidance on quality control of monoclonal antibodies, to incorporate new elements on immunogenicity, so that it can be reviewed by July. It will revise the CPMP note for guidance on gene therapy in light of what emerges from the overview now under way in the EU member states. Release for consultation is expected in December.
Changes also are to be made to the 1996 CPMP note for guidance on plasma-derived medicinal products. And a new CPMP guideline on comparability of biopharmaceuticals is being prepared for release in December.
Within the framework of the tripartite International Conference on Harmonization (ICH) of drug regulation in the U.S., the EU and Japan, it is expected to produce a consultation paper in March on the way to put into effect in Europe the recently agreed ICH specification for new biotechnological products.