Competent authority clinical trial application

Before a clinical trial can commence, it is necessary to submit a Clinical Trial Application (CTA) to the Competent Authority of each Member State, where it is 

The Competent Authorities are allowed a maximum of 60 days to review the data, or 90 days in the case of trials involving medicinal products for gene therapy, somatic cell therapy (including xenogeneic cell therapy), and all medicinal products containing genetically modified organisms. Such trials require written authorisation from the Competent Authority as distinct from other types of product where the authorities may just notify the sponsor of the acceptability (no-objection) of the application. If issues are raised, the sponsor may amend the application once, with a consequent extension to the allowed review period. 

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It is worthwhile to note that, in the US, where the applicant will just be dealing with a single authority, there is no need to re-submit data that was previously submitted as part of an IN D application to conduct clinical trials. Instead, the applicant can cross-reference the IND file. This does not apply in Europe, because clinical trial applications will have been submitted to individual Competent Authorities, whereas marketing authorisation applications are usually submitted either centrally to the European Medicines Agency (EMEA) or collectively to a number of Competent Authorities. Thus, the files need to be self-supporting. 

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). 

Before initiating a clinical investigation, the manufacturer (or his/her authorised representative) must prepare a statement containing the information outlined in Figure 10.2, and notify the relevant Competent Authorities of the proposed study. The manufacturer must also keep available for inspection by the Competent Authorities the information outlined in Figure 10.3. Unlike for clinical trials, a standard application form has not been developed. Instead, appropriate application forms are... 

The application for a clinical trial authorisation (CTA) for the first administration of a NME to man comprises the same elements as all other CTAs but, of course, there will be no clinical data. The regulatory authority known as the competent authority (CA) of the EU member state requires receipt of confirmation of the EU clinical trials database (EUDRACT) number, a covering letter, a completed application form, the protocol with all current amendments, the IB and a full Investigational Medicinal Product Dossier (IMPD) (see below). If the study is to be conducted in more than one member state, a list of CAs should be included. If the opinion of the lEC is available, it should be provided. 

With regard to reclassification, the new legislation requires that where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant or another MAH for a change of classification of the same substance for 1 year after the initial change was authorised. 

Clinical trials are regulated by individual member states in the European Union. An applicant (or sponsor) submits data on the investigational medicinal product (IMP), and details of the proposed clinical trial, to the competent authority in the country in which the trial is to be carried out. The ethics committee responsible for the site where the trial is to take place also needs to give approval. 

Member states have 60 days to consider a valid request from an applicant to conduct a clinical study, in the case of trials involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms an extension of a maximum of 30 days may be allowed. If the request to conduct a study is refused by the competent national authority, the sponsor may on one occasion only modify or amend the protocol to take account of the objections raised. No further appeal mechanism is provided. 

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