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Current Consultations
Consultation on the proposed amendments to Part II “Basic requirements for active substances used as starting materials” of the European Union (EU) guidelines to good manufacturing practice (GMP) and GMP Annex 13 “Manufacture of investigational medicinal products”
Deadline for comments 31 October 2008
[Comments on either of these documents should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008]
Public consultations have been launched on proposed amendments to Part II of the EU GMP guide and to GMP Annex 13 on investigational medicinal products.
Principles of Quality Risk Management have been included in Part II of the guide, which correspond to similar changes made to Part I Chapter 1 of the guide and published in February 2008. It should be noted that further changes to Part II of the guide beyond the implementation of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Q9 (Quality Risk Management) are currently not foreseen and would require proper discussion at ICH.
Based on practical experiences a revision of Annex 13 was deemed necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products and to the principle of independence between production and quality control functions.
Further information can be accessed from the EMEA.
Consultation on the proposed amendments to the European Union (EU) guidelines to good manufacturing practice (GMP) Annex 11 “Computerised systems”
Deadline for comments 31 October 2008
[Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008]
The European Commission has launched a public consultation on revisions of GMP Annex 11 on Computerised Systems and related changes in GMP Part I / Chapter 4 on Documentation. The Annex has been updated in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide on Documentation.
Further information can be accessed from the EMEA.
The Human Tissue Authority (HTA) codes of practice consultation
Deadline for comments is 14 November 2008
The Human Tissue Authority (HTA) is conducting a consultation on the HTA revised codes of practice. This includes a new code of practice on research.
For more information go to the HTA website.
Review of the General Medical Council’s (GMC’s) confidentiality guidance
Deadline for comments is 28 November 2008
The General Medical Council (GMC) is reviewing its guidance to doctors on ‘Confidentiality: Protecting and providing information (2004)’ and the accompanying Frequently Asked Questions. A consultation on the revised guidance is taking place.
For more information go to the GMC website.
Consultation on use of patient information for research
Deadline for comments is 10 December 2008
NHS Connecting for Health has launched a 12-week consultation to allow the public and healthcare professionals to have their say on the wider use of patient data. The results of the consultation will be used to shape how information held in the NHS Care Records Service is used other than for the purpose of providing direct care to patients. A series of workshops across England are also planned.
For more information go to the NHS Connecting for Health website.
GCP-compliant data management in multinational clinical trials
Deadline for comments is 31 December 2008
The Translational Working Group on Data Management of the European Clinical Research Infrastructure Network Phase 2 (ECRIN-2) has adopted Version 1 (15 September 2008) of Deliverable D10 on "GCP-compliant data management in multinational clinical trials". The document is open for comments, these should be sent via email to Prof. C. Ohmann (ohmannch@uni-duesseldorf.de).
International Conference on Harmonisation (ICH) release E2F: Development Safety Update Report (DSUR)
Deadline for comments December 2008
The International Conference on Harmonisation (ICH) E2F Development Safety Update Report (DSUR) has been released for consultation and is intended to establish a common standard for annual safety reporting among the ICH regions.
The guideline outlines the preferred content, format and timing of periodic reporting of safety information from clinical trials. The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors. Comments on this version should be emailed to ich@emea.europa.eu, the deadline for comment is December 2008. An electronic copy of the guideline can be accessed at the following link.
MHRA consultations on proposals for changes to regulatory fees from 1 April 2009
Deadline for comments 6 January 2009 (Devices) and 7 January 2009 (Medicines, blood establishments and blood banks)
The Medicines and Healthcare products Regulatory Agency (MHRA) have issued two consultations on their proposals to change the levels of regulatory fees charged by the MHRA for medicines, medical devices, hospital blood banks and blood establishments from 1 April 2009.
Consultation documents and instructions for responders are available at the following links:
Amended public consultation document an GMP Annex 13 on investigational medicinal products
Deadline for comments is 31 January 2009
The public consultation on Annex 13 to the GMP (investigational medicinal products) has been amended.
Based on practical experiences a revision of the Annex was deemed necessary to clarify certain points related to reference and retention samples, the two-step release procedure for investigational medicinal products, the principle of independence between production and quality control functions, and reconstitution.
The revised document can be accessed here.
Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 January 2009.
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