The European Commission (EC) has released a new proposal aimed at reforming Europe's pharmaceutical clinical trials regulations, dismantling an earlier attempt to modernize the rules and instead instituting an EU-wide harmonized approach. The new rules, previewed by European Commissioner for Health John Dalli at a 27 June meeting in Washington DC, will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC) once-or if-they are enacted in 2016. In a statement, ...

The European Commission has issued a proposal to revamp the rules governing clinical trials.   The proposed legislation will replace the "Clinical Trials Directive" of 2001, and will take the form of a regulation, ensuring that the rules for conducting clinical trials are identical throughout the EU.  In particular, it will make it easier to conduct multinational clinical trials in Europe. Some concrete proposals are: An authorization procedure f...

Right Direction, But is it Enough? In April 2001, Directive 2001/20/EC (the Clinical Trials Directive ) came into force with the objective of harmonizing clinical trial processes and detailing the legal provisions for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) across the EU. The aim was to increase and standardize the protection afforded to clinical trial participants. EU Member States were required to integrate these provisions into nation...

Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers to the agency. Health Canada said in April 2012 it is moving entirely to an eCTD format for all applications of pharmaceutical products after the non-eCTD applications were seen as a burden on the agency. "Health Canada is considering ending the Non-eCTD Hybrid Pilot at the e...

Health Canada is announcing its intent to shut down a pilot project currently used by sponsors who still wish to submit common technical documents (CTDs) in their physical format instead of the now-common electronic CTD (eCTD) format. Health Canada's pilot project, which involves the sponsor filling out CTDs in electronic format and submitting them in their physical form to Health Canada, was intended to be a "transitory aid for sponsors not yet ready to submit in eCTD f...

The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations. The program, announced 23 April, was originally launched as a pilot program in January 2012 meant to gauge the usefulness of the electronic submission process. EMA said in a statement it has seen "an increase in ...

The European Medicines Agency (EMA) launched a new pilot program on 12 March for submitting centralized marketing authorization applications (MAAs) via an electronic application. "The pilot is a key step forward in the Agency's drive towards the use of electronic applications as standard, using the Electronic Common Technical Document (eCTD) format," said the agency in a statement. "This is expected to simplify and speed up the application process by improving data ...