title: [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
abstract: Scientific advice for potential applicants for marketing authorization for medicinal products has been part of the tasks of the European Medicines Agency (EMEA) ever since its establishment in 1995, and has been of increasing significance. Based on Article 56(3) of Regulation (EC) No. 726/2004, this task is now the responsibility of an independent working group of the EMEA, the Scientific Advice Working Party (SAWP). National scientific and regulatory advice has also been part of the work of two national authorities in Germany, the Federal Agency for Medicinal Products and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) for several years, but has gained in significance especially over the past 3 years. The basis for advice at a national level is Article 71c of the Law on Administrative Procedures (Verwaltungs-Verfahrensgesetz), the Drug Law, the Guidelines for the Evaluation of Medicinal Products (Arzneimittelprufrichtlinien), and relevant guidelines defining the scientific state of the art. A company developing medicinal products may consult the EMEA or the national authority at any time in order to obtain opinions on the investigations and studies on the pharmaceutical, preclinical and clinical development required for a particular stage of development. In this context, the focus is exclusively on the data required for the planned authorization and the assessment of the evaluation strategy suggested by the company itself. The agreement between the company and the regulatory authority prior to marketing approval is designed to achieve a more effective development of the product and to obtain a more rapid decision on a future authorization procedure. An important component of the scientific advice procedure is the discussion between the company and the agencies. The results of this oral exchange is always summarised in writing. Advice is available for all medicinal products, including "orphan drugs". At the European level, the authorization procedure is prepared with the EMEA which provides administrative and legal support, whereas the scientific opinion itself is elaborated by the members of SAWP, and is adopted by CHMP after a maximum of 3 months following the application. In addition to the written opinions elaborated by two members of SAWP, acting as coordinators, and the internal discussion, the exchange of positions within a "discussion meeting" is also an important part of the European procedure. Scientific advice is a fee-paying procedure, with certain exceptions. Experience from previous advice from the EMEA and the BfArM has shown a certain acceleration in subsequent procedures. This experience, however, also shows very clearly that it is the data actually established in the investigation, especially on efficacy and safety, which are important for a successful and fast approval procedure.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. pdejas@bfarm.de
authors.forename: P
authors.initials: P
authors.lastname: Dejas-Eckertz
authors.forename: G
authors.initials: G
authors.lastname: Schäffner
mesh_terms: D026683:Advisory Committees / Q000331:legislation & jurisprudence* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D017408:Guidelines as Topic; D006801:Humans; D040541:Marketing / Q000331:legislation & jurisprudence*; D012017:Referral and Consultation / Q000331:legislation & jurisprudence / Q000592:standards