TMQA Latest News

Mandatory Use of Common Repository for Human Centralised Procedures

As of 10 July 2015, companies are required to submit their centralised procedure applications for human medicines to the EMA via eSubmission Gateway/Web Client only, rather than to individual Member States on CDs/DVDs or via the Common European Submission Platform (CESP). The applications submitted via the eSubmission Gateway/Web Client will be made available to all national competent authorities via a common online repository. The common repository has been available since Feb 2014 and enables national competent authorities to safely search, browse and download centralised procedure electronic common technical document (CTD) submissions for human medicines. The system is expected to accelerate the validation of incoming applications and will ensure continuous and immediate access to up-to-date dossiers by all national competent authorities.  http://tinyurl.com/prbgh4t


Mandatory EU Common Logo for Selling Drugs Online

From 1 July 2015 anyone in the UK selling medicines online to the general public in the UK or another European Economic Area (EEA) country needs to be registered with the MHRA and be included in the MHRA’s list of UK registered online retail sellers. In addition, the new EU common logo must be displayed on all pages of the website offering the medicine(s) and contact details of the MHRA and a link to the MHRA’s website must be included. The registered EU common logo will contain a hyperlink to the company’s entry in the MHRA’s list of registered online sellers. Anybody buying medicines online can check if the website is legitimately registered and will be able to click on the logo which will take them through to a list of registered sellers. The European Commission has generated technical guidance on using the logo, which can be found at: http://tinyurl.com/nftn65s

Falsified medicines are a major threat to public health and safety and hence the aim of the new EU common logo is to help members of the public to identify websites that can legally sell medicines. The penalty for selling medicines online without being registered and not displaying the logo is up to 2 years in prison or a fine or both. http://tinyurl.com/plm56sj


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