Latest regulatory and governance news
Website of the Month
Each month, the UKCRN Regulatory and Governance Team will highlight a website which provides useful information and/or resources:
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European Commission publish revised clinical trial application form The European Commission has published a revised version of the clinical trial application form incorporating new items relating mainly to implementation of the Paediatric Regulation (EC) No 1901/2006. The new clinical trial application form dated June 2008 will be applicable only once the EudraCT database Version 7 has been released. This is expected for Q1 2009. Please note that the form is likely to undergo at least one further revision (to incorporate Advanced Therapy Investigational Medicinal Products) prior to implementation of Version 7. Further information is available
here. Projects funded by the US Department of Health and Human Services (DHHS) must be reviewed by a designated NHS Research Ethics Committee (REC) With immediate effect, all research projects funded by the US Department of Health and Human Services (DHHS) must be reviewed by a NHS research ethics committee (REC) flagged for this purpose and which is registered with the US Office for Human Research Protections (OHRP) as an Independent Ethics Committee. Further information is available
here.
Integrated Research Application System (IRAS) update The consultation-in-use phase of Integrated Research Application System (IRAS) ran from January to June 2008. This phase has now closed. Researchers are strongly encouraged to begin new research applications on IRAS now to take advantage of the increased functionality and benefits of the integration IRAS offers. As data cannot be transferred from the old ethics and R&D on-line application forms to IRAS, and as IRAS will be the entry point to other systems including the National Institute for Health Research Co-ordinated System for Gaining NHS Permission (NIHR CSP) in England, researchers and research managers are strongly encouraged to familiarise themselves with and start using IRAS now. Further information about IRAS can be accessed
here.
Concordat to support career development of researchers
A new Concordat to support the career development of researchers has been launched by Iain Pearson, the Minister for Science and Innovation. The Concordat to Support the Career Development of Researchers sets out the expectations and responsibilities of researchers, their managers, employers and funders. This meets the principles of the European Charter and Code of Practice for the recruitment of researchers. The Department of Health is a signatory to the concordat. More information can be accessed at
here. New rules come into force for the collection of cord blood New rules came into force on 5 July that requires the collection of cord blood to take place under the authority of a licence from the Human Tissue Authority (HTA). All maternity units, or third parties engaged to collect cord blood will need to act under a HTA licence that will ensure:
- Staff have training in collecting cord blood, raising standards and making sure that best possible quality of sample is taken.
- Procedures which will help prevent any medical attention being drawn away from mother or child during collection.
- The risk of contamination to the sample is minimised
- A system is in place to make sure that the cord blood cells are traceable from collection to their use in treatments.
Further information is available on the
HTA website.
Implementation of the Advanced Therapies Regulation: Outcome of the public consultation on amendments to Annex I to Directive 2001/83/EC
From 8 May to 10 June 2008, a public consultation was conducted on draft amendments to Annex I to Directive 2001/83/EC as regards advanced therapy medicinal products. The
summary outcome of the public consultation paper is now available on the Commission website.
Overview of comments received on the European Medicines Agency (EMEA) draft guideline on cell-based medicinal products The European Medicines Agency (EMEA) has posted a copy of the comments received during its consultation on the draft guideline on cell-based medicinal products. The consultation document addressed the development, manufacturing and quality control, as well as non-clinical and clinical development of cell based medicinal products. A
copy of the comments can be downloaded from the EMEA website.
Medicines & Medical Devices Regulations: What you need to know
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a short brochure providing an introduction to the agency and how it regulates medicines and medical devices in the UK.
Sections include:
- What is the MHRA?
- How does licensing and authorisation work?
- How does the MHRA monitor safety and quality standards?
- Influencing policy
A
copy of the leaflet can be downloaded from the MHRA website.
Reminder for applicants making electronic payments to the Medicines and Healthcare Products Regulatory Agency (MHRA)
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a reminder to all applicants making electronic payments to ensure that an identifiable reference number is quoted on their payment instruction, for clinical trials payments this would be the clinical trial (CT) reference number. Payments received without a reference number may delay the granting of an application. Further information can be accessed on the
MHRA website. The European Medicines Agency (EMEA) accepts electronic-only marketing-authorisation submissions from 1 July 2008 Since 1 July, the European Medicines Agency (EMEA) has begun accepting electronic-only marketing-authorisation applications (whether in eCTD or non-eCTD format) for medicinal products for human use in the centralised procedure. Further details on electronic-only and eCTD submissions are available in the Q&A documents which are available on the EMEA website.
Q&A relating to strategic and general aspects can be accessed
here.
Q&A relating to practical and technical aspects can be accessed
here.
Pre-submission dossier requirements can be accessed
here.
Post-authorisation dossier requirements can be accessed
here.
Pre-submission and post-authorisation procedural-advice documents can be accessed
here (please bear in mind that these are currently being updated to reflect the revised dossier requirements).
The European Medicines Agency (EMEA) proposes a pilot programme to rationalise international Good Manufacturing Practice (GMP) inspection activities
As part of its collaboration with international medicines regulators on good manufacturing practices (GMP) inspections, the European Medicines Agency (EMEA) has coordinated a group of participating regulators (EU Member States, US Food and Drug Administration and Australian Therapeutic Goods Administration) and published a proposal for the coordination inspection plans between them.
The proposal forms parts of international efforts to rationalise the use of global GMP inspection resources by simplifying the administrative tasks relating to inspections and by avoiding the unnecessary duplication of inspection work.
The outline pilot project paper is available
here.
The US Food and Drug Administration (FDA) issue guidance on electronic regulatory submissions The US Food and Drug Administration (FDA) have issued a series of guidance documents intended to assist applicants making regulatory submissions to the FDA in electronic format using the electronic common technical document (eCTD) specifications. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling.3 At this time, this does not include applications supporting combination products.
This guidance revises the guidance of the same title that was issued in October 2005 and revised in April 2006.
Further information is available on the
FDA website. The European Commission updates Volume 10 (Guidelines for Clinical Trials) of “The rules governing medicinal products in the European Union” The European Commission has updated the EudraLex guideline Volume 10 on clinical trials. In particular the following parts have recently been updated - chapter I: application and application form, chapter IV: recommendation on inspections and chapter V: additional information. These can be accessed
here.
Data Sharing Review Report The Report of the Data Sharing Review undertaken by Richard Thomas, the Information Commissioner, and Dr Mark Walport, the Director of the Wellcome Trust has been published. The report includes specific recommendations relevant to clinical research and statistical analysis (recommendations 15 – 17). The report can be accessed
here. New arrangements for ethical review of Establishment of Research Databases The National Research Ethics Service (NRES) has now flagged a number of Research Ethics Committees (RECs) to review applications for the Establishment of Research Databases. NRES has recommended that researchers should book their applications via the Central Allocation System to one of the RECs designated below and that their applications are made using the
Integrated Research Application System (IRAS).
Northern Ireland Health and Social Care Research Ethics Committee 1 (HSC REC 1)
South England Lewisham Research Ethics Committee
North England Newcastle and North Tyneside Research Ethics Committee 1
South England North Somerset and South Bristol Research Ethics Committee
North England North West Research Ethics Committee
South England Oxfordshire Research Ethics Committee C
South England South East Research Ethics Committee
North England Trent Research Ethics Committee
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