Clinical Trial Approvals (CTA); (IND)

Clinical Trial Authorisations (CTA); Investigational New Drug applications (IND); Regulatory Affairs Services

Under the Clinical Trial Directive 2001/20 EC* authorisation by the relevant National Competent Authority is required to conduct trials on human volunteers or patients in any EU member state.

The application requirements are nominally harmonised across the EU but national procedures vary.

The procedure involves obtaining a EudraCT number from the European Medicines Agency (EMA) and submitting an application for Clinical Trial Authorisation (CTA) to the Competent Authority of each member state where the trial will be conducted.

vector pharma can advise on the regulatory affairs requirements for and preparation of the necessary documents constituting the CTA and deal with correspondence between the Competent Authorities and relevant sponsor, or legal representative.

Documents which in particular we can help to prepare include:

Application form

EudraCT XML file

Investigators brochure (IB)

Investigational medicinal product dossier (IMPD)

In the US we can help to facilitate pre-IND meetings with the FDA and assist with preparation of the IND application.

*Clinical Trial Directive 2001/20 EC of  the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121, 1/5/2001 p. 34 – 44)