The number of Good Clinical Practice (GCP) inspections in third countries, carried out by inspectors of the national competent authorities of EU Member States, increased more than four-fold between 2006 and 2011. And the top three countries in which Inspected bioequivalence studies were India, Italy and Canada.
This is what emerges from a report by the European Medicines Agency (EMA) which specifies: both routine checks and checks activated over the years have increased. Routine inspections - explains the EMA - are required as part of the continuous quality control of the studies submitted as part of the MA applications, while activated controls are required when the evaluators identify specific problems on the report and on the data relating to a trial that requires specific investigation by inspection.
A total of 357 sites were inspected between 1997 and 2011 at the request of the Agency's Committee for Medicinal Products for Human Use (CHMP), but most of the audits have taken place since 2007. The pivotal studies presented between 2005 and 2011 involved 70,291 survey sites. The United States (21.6%) is the country outside the EU/EEA/EFTA area with the highest number of required controls, followed by India (4.5%), Canada (4.5%), Russia (3.1%), Argentina (2.2%) and China (1.7%). All clinical trials included in an MA application presented in the EU - highlights the EMA - must meet EU legal requirements, international GCP (Good manufacturing practice) standards and ethical standards wherever they have been set in the world. carried out. It is the applicant's responsibility to ensure compliance with these standards.
In 2012, EMA published a Reflection Paper on the ethical and GCP aspects of clinical trials conducted outside the EU/EEA and presented in MA applications submitted to EU regulatory authorities. The document proposed concrete measures for international cooperation in the regulation of clinical trials, with particular emphasis on international cooperation and capacity-building initiatives for a common approach to trial supervision. It also clarifies and determines the concrete measures by which EU regulators can obtain assurances that GCP and ethical standards are applied to clinical trials for human medicines, both during development and during the MA application phase.
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