title: Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.
abstract: BACKGROUND
  In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.
  
  
  METHODS
  We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries.
  
  
  RESULTS
  Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised.
  
  
  CONCLUSIONS
  The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.
authors.affiliation: Copenhagen Trial Unit-CTU, Centre for Clinical Intervention Research, and the Danish Clinical Research Infrastructures Network-DCRIN, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. cgluud@ctu.rh.dk
authors.forename: Christian
authors.initials: C
authors.lastname: Gluud
authors.forename: Christine
authors.initials: C
authors.lastname: Kubiak
authors.forename: Kate
authors.initials: K
authors.lastname: Whitfield
authors.forename: Jane
authors.initials: J
authors.lastname: Byrne
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Huemer
authors.forename: Steffen
authors.initials: S
authors.lastname: Thirstrup
authors.forename: Christian
authors.initials: C
authors.lastname: Libersa
authors.forename: Béatrice
authors.initials: B
authors.lastname: Barraud
authors.forename: Xina
authors.initials: X
authors.lastname: Grählert
authors.forename: Gabriele
authors.initials: G
authors.lastname: Dreier
authors.forename: Sebastian
authors.initials: S
authors.lastname: Geismann
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kuchinke
authors.forename: Zsuza
authors.initials: Z
authors.lastname: Temesvari
authors.forename: Gyorgy
authors.initials: G
authors.lastname: Blasko
authors.forename: Gabriella
authors.initials: G
authors.lastname: Kardos
authors.forename: Timothy
authors.initials: T
authors.lastname: O'Brien
authors.forename: Margaret
authors.initials: M
authors.lastname: Cooney
authors.forename: Siobhan
authors.initials: S
authors.lastname: Gaynor
authors.forename: Arrigo
authors.initials: A
authors.lastname: Schieppati
authors.forename: Fernando
authors.initials: F
authors.lastname: de Andres
authors.forename: Nuria
authors.initials: N
authors.lastname: Sanz
authors.forename: German
authors.initials: G
authors.lastname: Kreis
authors.forename: Charlotte
authors.initials: C
authors.lastname: Asker-Hagelberg
authors.forename: Hanna
authors.initials: H
authors.lastname: Johansson
authors.forename: Sue
authors.initials: S
authors.lastname: Bourne
authors.forename: Adeeba
authors.initials: A
authors.lastname: Asghar
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Husson
authors.forename: Jacques
authors.initials: J
authors.lastname: Demotes-Mainard
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence* / Q000592:standards; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D033161:Government Regulation; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006291:Health Policy; D006801:Humans; D007391:International Cooperation / Q000331:legislation & jurisprudence; D011795:Surveys and Questionnaires
chemical_list: D015507:Drugs, Investigational