TMQA Latest News

Electronic Application Forms become Mandatory for all Centralised Marketing Application Authorisations

As of 01 July 2015, the use of electronic application forms provided by the EMA for all centralised marketing authorisation applications for human and veterinary medicines became mandatory. Forms can be downloaded from the electronic Application Forms (eAF) website: http://esubmission.ema.europa.eu/eaf/index.html. The electronic application forms reflect and capture the same content as the previous paper-based versions. Their use is expected to reduce the administrative burden for both the regulatory authorities and pharmaceutical companies. The electronic forms were initially released in 2012 and have been significantly improved since that time following feedback received. From January 2016, the use of electronic application forms will also be mandatory for all other EU marketing authorisation procedures for human and veterinary medicines, i.e. the decentralised procedure (DCP), mutual recognition procedure (MRP) and for national submissions. http://tinyurl.com/oz8xxmp


MHRA Updates Phase I Accreditation List

The MHRA updated their list of accredited phase I units in June 2015. The updated list can be found at: http://tinyurl.com/o7ayg34

The MHRA’s phase I accreditation scheme is a voluntary scheme for organisations conducting phase I clinical trials, in particular for those conducting first in human (FIH) trials. Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards for avoiding harm to trial subjects and for handling any medical emergencies.


Addendum to ICH E6

Since the adoption of the ICH E6 Guideline on Good Clinical Practice (GCP) in 1996, clinical trials have evolved substantially, with increases in globalisation, study complexity and technological capabilities. To keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology, the approach to GCP should be modernised to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. Although ICH E6 generally has been interpreted as providing sponsors flexibility to implement innovative approaches, it has been misinterpreted and implemented in ways that impede innovation by, for example, emphasising less important aspects of trials (e.g. focusing on the completeness and accuracy of every piece of data) at the expense of critical aspects (e.g. carefully managing risks to the integrity of outcome data). Modernising ICH E6 by supplementing it with additional recommendations will better facilitate broad and consistent international implementation of new methodologies. As a result, an addendum to ICH Topic E6 (Good Clinical Practice) was endorsed by the ICH Steering Committee in June 2014 and the last face-to-face ICH E6 Expert Working Group (EWG) meeting took place in Japan in June 2015 during which the work plan was updated as follows

Date

Task/Activity

Details

Jun 2015

Face to face meeting

·         Agreed on the addendum language and reached Step 1 draft

·         Updated the work plan

Jul 2015-Jan 2016

Public consultation by ICH and regional regulators

·         Gathering comments for review

Sep–Nov 2015

Webconferences (3)

·         Reviewing and resolving comments received form public consultation

Dec 2015

Face to face meeting

·         Resolve public comments and start drafting final document

 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html


EMA Update on Publication of Clinical Trial Data

On 24 June 2015, the EMA held a webinar to provide an update on the implementation of its policy on the publication of clinical data which came into effect on 01 January 2015. The topics covered in the webinar included an explanation of the principles for the submission of redacted clinical reports, the redaction consultation progress as well as guidance on what is and is not considered commercially confidential information and on the anonymisation and redaction of personal data in clinical reports. The video recording of the webinar as well as slides of all the presentations given have now been published on the EMA website and can be found on:

http://tinyurl.com/pfxo6bg


TMQA strengthens partnership with BioCity Scotland

We are delighted to announce that TMQA has strengthened its relationship with BioCity Scotland by upgrading from Service Associates to Corporate Partners.  As Service Associates the TMQA team provided an onsite “drop in” QA advice service for tenants two days a month.   Over the last two years, we have supported several tenants by providing advice on regulatory requirements and compliance, supporting the implementation of quality management systems and conducting independent GMP (Good Manufacturing Practice) audits.

TMQA Director, Andrew Waddell, commented: “Developing a closer relationship with Biocity and its tenants gives them access to a range of Quality Assurance services which can change and develop along with their companies.  Using our ‘pay-as-you-go’ service means that they don’t need to invest in the overhead costs of hiring their own QA staff – they can use TMQA services whenever they need and only pay for the actual time involved.   Active partnering with organisations – small or large – is at the core of our business plan and our relationship with Biocity is an exciting development for us.”