1. Introduction to the survey

7% of survey complete.

The FACT-JACIE Standards require facilities to be authorised, licenced or certified or in general to perform in accordance with applicable laws and regulations. Increasingly JACIE uses inspectors from outside the country where the inspection is taking place. This adds extra objectivity and fresh points of view. At the same time, the inspectors are not familiar with regulations or requirements specific to that country.

Objective of this survey

The aim of this survey is to collect basic information via the national representatives on the different national regulations relevant to the JACIE Standards. With the results of the survey, we will be able to provide the inspectors with a list of information that they should expect to see during the inspection.
The survey asks about the following:
  • Which authorities register, authorise or certify establishments and what document(s) would demonstrate this authorisation?
  • Physician licensing requirements and how this would be demonstrated
  • Consent requirements for minor donors
  • Authorisation requirements for donor-testing laboratories
  • Infectious disease markers - testing and/or risk assessment requirements
  • Product coding and labelling e.g. ISBT128
  • Single European Code implementation
  • Approval of investigational treatment protocols
  • Collection and Processing equipment legal requirements
  • Test reagent and kit legal requirements
Please write your answers in a way that can be understood by inspectors who are unfamiliar with the specific regulations.

The information collected previously can be found at https://www.ebmt.org/regulations-guidelines