The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has recently updated several guidance documents concerning the submission, processing...[more]
The Hungarian National Institute of Pharmacy (NIP) has updated their national submission requirements for medicinal products for human use. According to the new requirements, the...[more]
In a recent meeting of the Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)), it was decided to inform applicants that as of 1st June 2011,...[more]
The EU Telematics Implementation Group for electronic submissions (TIGes) released new validation criteria for eCTD and NeeS. The first proposal for the new validation criteria...[more]
The U.S. Food and Drug Administration has released a new draft guidance "PET Drug Applications — Content and Format for NDAs and ANDAs" intended to assist applicants in...[more]
The Coordination Group for Mutual and Decentralized procedures - Human (CMD(h)) has released an updated version (CMDh/132/2009/Rev9) of the Q/A list for the submission of...[more]
In their last eCTD-relevant update from December last year (see related News article here), the Swiss Drug Regulatory Agency Swissmedic did release (amongst others)...[more]
