Current Consultations

The National Cancer Intelligence Network (NCIN) response to the consultation on access to samples and data for cancer research

The National Cancer Research Institute (NCRI), in collaboration with the National Cancer Intelligence Network (NCIN) and onCore UK, ran a consultation on access to sample and data for cancer research.  A summary document detailing the range of opinions expressed, highlighting areas of general consensus, and of difference is available from the NCRI website.

Human Fertilisation and Embryology Authority (HFEA) consultation on the draft 8th Code of Practice and revised consent forms
 
Deadline for comments is 18 February 2009

The HFEA would like your views on the draft 8th Code of Practice and a number of revised patient consent forms.

The new Code of Practice and consent forms have been written to:

• help clinics meet new legislative requirements
• introduce some changes in guidance in response to feedback from patients and licensed clinics
• take the opportunity to improve the style and layout of both the Code and the consent forms to improve clarity and usability.

Further details are available at here.

Consultation on proposed Human Tissue Authority (HTA) new licence fee structure

Deadline for comment 5 March 2009

You are invited to take part in a consultation on the HTA’s proposed new licence fee structure. As engagement is one of the HTA’s founding principles, they would value your feedback to the consultation, particularly to understand the effect that an increase in the licence fee charge will have on your establishment and sector.

Further information is available from the HTA website.

Impact of human tissue legislation and regulation on research
The Human Tissue Authority (HTA) is undertaking an independent review of recent human tissue legislation has impacted on the research community, and how it has been implemented by the HTA. Responses will feed into a future review of the Human Tissue Act and inform the HTA’s advice and guidance. If you feel that this project is relevant to you and want to take part please email hta@opinionleader.co.uk or phone 020 7861 3802 with your name, telephone number, institute and position and someone will get back to you. The research will start on 9 February and you will not be approached before then. If you have any questions about the project please ring Joanna Bibby-Scullion at Opinion Leader on 020 7861 3080. If you would like to speak to someone at the HTA, please contact Daisy Thomas, HTA Head of Communications, on 020 7211 3417.

Concept paper on MHRA project to consolidate and review medicines legislation

Deadline for comments 27 March 2009

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking the input of stakeholders into the project on the review and consolidation of medicines legislation. The concept paper identifies a number of areas where possible reforms can be made. The MHRA would welcome views from stakeholders on the areas that are outlined, and other areas which you feel warrant attention. Full details are available from the MHRA website.

Public consultation on revisions of GMP Annex 14 on "Manufacture of medicinal products derived from human blood or plasma"

Deadline for comments 31 July 2009

The annex has been revised in the light of Directive 2002/98/EC and relevant implementing directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. These directives apply to the collection and testing of blood for all uses, including the manufacture of medicinal products.

Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu.