The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) has released its latest Joint Position which will require member companies to disclose information on all clinical trials in patients. This new requirement will now extend to early-stage safety trials of medicines for life-threatening conditions. Member companies will still maintain discretion to disclose information from Phase I safety trials in health volunteers.
The Joint Position has already been approved by pharmaceutical associations from Japan, Europe and the United States respectively. Once the position comes into force, member companies will be responsible for posting details of new clinical trials in patients on a publicly accessible website within 21 days of the start of the patient enrolment. There will also be a requirement for member companies to publish summary result of the trials within one year of the relevant product being tested.
More detailed information can be accessed at the site below: http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13083