GMP NEWS 2011

In a press release the EMA announced the publication of a final report on the International API Inspection Programme. The report presents the results of a 2-year international collaboration between competent authorities from Europe, Australia, FDA and EDQM. Read more here.

In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed to by the Biologics Working Party and adopted by the CHMP/CAT. Read more here.

Every year the ECA Foundation Advisory Board conducts its annnual meeting to review past and determine future activities. Read more about the developments and planned activities.

The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) published the draft of the revised 'Guideline on Good Distribution Practice of Medicinal Products for Human Use' for public consultation. The guideline has been completely revised. Read more.

The WHO has incorparated a new section on "Product Quality Review" in its GMP Main Principles for Pharmaceutical Products. Read more.

In June the ECDC (European Centre for Disease Prevention and Control) published a technical report on the prevention of Creutzfeldt-Jakob (vCJD) disease transmission in medical settings in EU Member States and Norway. Read more.

The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.

The WHO Expert Committee published  their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.

Because of the extensive reorganisation of applications for variations contained in the Variations Regulation from 2010, a revision of the "Guideline on stability testing for applications for variations to a marketing authorisation" became necessary. Read here, which stability testing data are required by regulatory authorities in case of applications for variations.