Scientific and Regulatory Advice through the Federal Institute for Drugs and Medical Devices (BfArM)
Guidance for Applicants (Revision 1*) dated 23 May 2006) including Comments of the Verband Forschender Arzneimittelhersteller e.V. (VFA)
Following the “Joint Notification on the issuing of advice to applicants during marketing authorisation procedures and to marketing authorisation holders in other authorisation procedures” dated 4 September 1998 and issued by the BfArM, the Federal Institute for Consumer Protection and Veterinary Medicines (BgVV) and the Paul Ehrlich Institute (PEI), the BfArM first published additional information concerning the advice procedure on 12 February 2003.
The VFA subsequently prepared its own comments from the standpoint of pharmaceutical research-based companies and these were directly integrated into the BfArM document and published in this journal (Pharm. Ind. 66, No. 3, pp. 271−276; 2004). An updated and expanded version of the additional information issued by the BfArM appeared on 23 May 2006 and contains important further developments. These include a clearer distinction between the advice provided in the development phase (Scientific Advice) and that provided before submission (Pre-Submission Meeting). An application form has also been introduced to facilitate the validation of applications for advisory meetings.
Another innovation is the introduction of portfolio meetings, which give companies the opportunity to present an overview of their development activities at a relatively early stage, thereby enabling possible regulatory strategies to be discussed and facilitating the medium-term planning of scientific and administrative resources at the BfArM. These discussions can also serve as starting points for subsequent national advisory procedures for individual projects.
The Drug Regulatory Affairs subcommittee of the VFA has also prepared comments relating to this new version with specific helpful suggestions for applicant companies. These have again been integrated in the BfArM text. The BfArM document, including the VFA comments, is reproduced below.
*) This version replaces the Guidance for Application dated 12. 2. 2003.