After a successful test phase, ANSM has decided to maintain its two accelerated circuits for medicinal product clinical trial authorisations (Fast Track). These circuits were established on 15 October 2018 as an initial test run and on a voluntary basis to reduce clinical trial authorisation...
Read moreAs mandated in Article 4 of Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (ATMPs), the European Commission has published guidelines on good clinical practice (GCP) specific to ATMPs. The 15-page document should be read in conjunction with ICH E6 Guidelines on GCP , which are...
Read moreClinical trials are an important step during drug development, leading towards marketing authorisation and thus, market access. According to §40 German Drug Law / §7 GCP ordinance, clinical trials have to be approved by the responsible competent authority (CA). Recently, both German CAs (the...
Read moreIt has been over a year since the EMA implemented Policy 0070 on the Publication of Clinical Trial Data; the EMA have published a guidance document and a report of the first year since it was launched (Oct 2016-Oct 2017). Under Policy 70, clinical data has now been published for over 50 products,...
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