The European Medicines Agency (EMA) publishes “Reflection Papers” to communicate expectations to industry.
This draft guidance was released for public comment in August, 2011. The comment period extends through February 15, 2012.
In August 2011, an independent Computer System Validation study group produced this English translation of the Q&A document that accompanies the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drags and Quasi-drugs.
In August 2011, an independent Computer System Validation study group produced this English translation of the 2010 Japanese Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs.
On 15 July 2011, the EU Commission published this draft guidance, Guideline on Good Distribution Practice of Medicinal Products for Human Use, for public consultation. The deadline for comment is ending on 31 December 2011. This is the first update to GDP directive from 1992.
Please see the following sections for specifics:
This 1992 European Commission guidance, Guideline on Good Distribution Practice of Medicinal Products for Human Use, does not elaborate on any specific requirements for computers or software. However, the 2011 draft update to this document does.
The 2011 draft is also available on the Validation Center site.
This document contains the cumulative directives of the European Parliament and Council from October 1998 through August, 2009 regarding in vitro diagnostic medical devices.
This document contains the cumulative directives of the European Parliament and Council from June 1990 through October, 2007 regarding active implantable medical devices.
This document contains the cumulative directives of the European Parliament and Council from June 1993 through November, 2007 regarding medical devices.
In January, 2011, the European Commission published a new version of Annex 11, Computerised Systems with an effective date of June 30, 2011.
The European Medicines Agency (EMA) has published answers to frequently asked Annex 11 questions.
April 2011 FDA Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of theCompatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)
