ࡱ> .0-%` bjbjNN .,, :T "J2BBBBB$|hjVVVBBV:BBVYB6 )Rq0Jy,NNN$>[,$JVVVVR R $6 Exploratory clinical trials General: The number of new medicines that progress throughout the full development to a final market authorisation is low. Furthermore involves the development of new medicines a lot of resources, efforts and costs. There is consequently a big demand for exploratory clinical trials in humans to find the most promising products for clinical development. This guidance is a working document for exploratory clinical trials in Belgium awaiting more concrete guidelines on European level. This means also that it is a document that still can evolve and can be optimized in harmonisation with EMEA. With this document it has been made possible to request these trials in Belgium and to conduct them after authorisation from the competent authority (R&D) and the ethics committee. Practical: Demands for an exploratory clinical trial can be submitted starting from 21 June 2007. For every request to conduct an exploratory clinical trial the same price as for any other CTA has to be paid on the following account number: 679-0001514-59 The treatment of every request starts only when we received the (pre submission) file and the proof of payment. For every request a separate payment is asked with the announcement EudraCT, followed by the eudraCT number and the notice EXPLORATORY. Procedure: The applicant of an exploratory clinical trial is highly recommended first to request a pre submission and should write a letter indicating the EudraCT number, the announcement that is a request for an exploratory clinical trial and the following: A brief outline of the goal of the intended study An overview of the planned pre-clinical experiments The type of substance (chemical biotech) The quality and pre-clinical data that will be available at the time of submission, as well as the protocol design, etc.. The questions that the applicant may have about regulatory aspects concerning the planned trial. Whit this information a decision can be made whether and how further explanation may be required. Once the actual data are submitted as an IMPD, we may still exceptionally propose a meeting or a teleconference to solve any major concerns that did arise in the most efficient way. After submission of the definitive file, the exploratory clinical trial will be treated within 15 calendar days, the same timeline as a phase I trial. Attention must be made to the fact that per additional substance the timeline will be prolonged with 3 days. This is not laid down by law, but we advise you to pay attention to this in function of your planning. The 15 days timeline starts from the moment the department R&D has received the definitive file and not from the moment of pre submission. The start of the timeline will be confirmed with a confirmation email to the applicant. '0 ;  # 2 1 < +ho.> ho.>>* h>*h5>*\hZSh'( w x . / 0 ; < 2 3 / 0 1 < = 5&$$d%d&d'dNOPQa$5g@* & F,1h. A!"#$% @@@ NormalCJ_HaJmH sH tH >@> Heading 1$@& 5CJ$\DAD Default Paragraph FontViV  Table Normal :V 44 la (k(No List   "& "& n'(wx./0;<23/01<=5g@*    p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#p#'(wx./0;<23/01<=5g@*    000000000000000000000000 0 0 0 0 0000000000'(wx./0;<23/01<=5g@*    000000000000000000000000 0 0 0 0 0000000000 5  8@0(  B S  ?eT;eTP eTTN!eTlH  B*urn:schemas-microsoft-com:office:smarttagscountry-region9*urn:schemas-microsoft-com:office:smarttagsplace @4   =? :(1=  y%JT^`OJPJQJ^Jo(- ^`OJQJo(o pp^p`OJQJo( @ @ ^@ `OJQJo( ^`OJQJo(o ^`OJQJo( ^`OJQJo( ^`OJQJo(o PP^P`OJQJo(y%4y        o.>ZS@`K @UnknownGz Times New Roman5Symbol3& z Arial?5 z Courier New;Wingdings"qhSFSFm m $24d  3QHX)?2Exploratory clinical trialsttstt Oh+'0x  4 @ LX`hpExploratory clinical trialsttNormalstt2Microsoft Office Word@Ik@1@1m ՜.+,0P hp  Ministry of Social Affairs ' Exploratory clinical trialExploratory clinical trial TitleTitre  !"#$&'()*+,/Root Entry F8R11Table^WordDocument.SummaryInformation(DocumentSummaryInformation8%CompObjq  FMicrosoft Office Word Document MSWordDocWord.Document.89q