BayBiotech.NET
When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts.
This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site outside EU members, whether it is in Japan, Australia, Canada or United States will have to follow all the above mentioned directives to be in compliance. Similarly, if a drug is developed and clinical trials are conducted in United States or any other country following FDA GCP guidelines will have problems getting marketing clearance within EU member states as the trial may have only followed FDA GCP but not EU directives.
Seems with globalization of the clinical trials and drug discovery efforts, a revision of harmonization is due and till then a clear expert understanding of local regulations of the countries where trial sites are selected will be helpful. Note that the country of choice for clinical trials must be followed closely for their local regulations as amendments are incorporated all the times and in order to get a higher success rate with the trial data acceptance a close follow-up on local GCP regulations will be helpful.
When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts.
This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site outside EU members, whether it is in Japan, Australia, Canada or United States will have to follow all the above mentioned directives to be in compliance. Similarly, if a drug is developed and clinical trials are conducted in United States or any other country following FDA GCP guidelines will have problems getting marketing clearance within EU member states as the trial may have only followed FDA GCP but not EU directives.
Seems with globalization of the clinical trials and drug discovery efforts, a revision of harmonization is due and till then a clear expert understanding of local regulations of the countries where trial sites are selected will be helpful. Note that the country of choice for clinical trials must be followed closely for their local regulations as amendments are incorporated all the times and in order to get a higher success rate with the trial data acceptance a close follow-up on local GCP regulations will be helpful.
Comments
Post a Comment