Bioequivalence and Bioavailability Forum

❝ Is it permitted in GCP to make any amendment in the Letter of Decision of the approval of protocol by the Ethics Committee? For example, in that approval letter, some important information like the brand name of the test product and of the sponsor is missing. Can Ethics committee issue an amendment to cover those lacking information?

Dear Mr Jasim Uddin,

Only if the brand name of the test product and sponsor name is missing in the EC approved letter of decision, then amendment to approval letter can be provided by the Ethics committee. But, issuing such amendment to approval letter should be captured in the EC's Relevant SOPs. In my opinion, since the protocol number was going to be same and the protocol which was submitted to the Ethics committee contains those details, issuing such amendment letter will not raise any regulatory concern.