Guidance is available for clinical-trial sponsors on how they should adjust the management of In line with this guidance, EMA will be flexible and pragmatic during the assessment of affected Assessments are based on purely scientific criteria and determine whether or not the medicines concerned meet the necessary quality, safety and The Agency is responsible for the development, maintenance and coordination of the A subset of this data is made available through the The content and level of detail of these summary results is set out in a European Commission On 3 July 2019, EMA published a letter co-signed by the European Commission and the As of October 2016, the Agency publishes clinical reports submitted by pharmaceutical companies to support their regulatory applications for human medicines under the In April 2012, the Agency published the final version of this paper:This paper aims to strengthen existing processes to provide assurance that On 16 April 2014 the European Commission adopted the new The Group is composed of representatives from the clinical-trial departments of the
Clinical trials are studies that are intended to discover or verify the effects of one or more investigational medicines. Bioethics, legal and economic issues
EU Clinical Trials Register version 2.2 . Last update: 21 Nov 2016 ... Additional guidelines detailed in chapter V of EudraLex - Volume 10 consisting of three "mother guidelines" (Guideline 2008/C168/02, Guideline 2009/C28/01, Guideline 2012/C302/03), set out the principles, responsibilities, and procedural aspects of implementation. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible.. The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences.
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Guidelines on the conduct of Clinical Trials.
Clinical trials are essential for the development of medicines and without them patients cannot gain access to new, potentially life-saving medicines.
For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). EMA Revises the Guideline on First-in-Human Clinical TrialsChanges are open for comments until end of February 2017
How to get a marketing authorisation for a regenerative medicine so it can be sold and supplied in the UK and Europe.An advanced therapy medicinal product (ATMP) is a medicinal product which is either:If you are not sure if your product is an ATMP or which type of ATMP it is, please look at this MHRA or EMA will classify your product as an ATMP if appropriate.All regulatory enquiries about regenerative medicines should go through the The Innovation Office is the single point of contact for all the regulators involved in regenerative medicines:To contact the innovation office either fill out the All advanced therapy medicinal products must go through All ATMPs to be placed on the market in the EU must have a marketing authorisation and are regulated through the The Committee for Advanced Therapies (CAT), established by the European Medicines Agency (EMA), is responsible for preparing a draft opinion on the quality, safety and efficacy of each ATMP that needs a marketing authorisation.The CAT’s opinion goes to EMA’s Committee for Medicinal Products for Human Use (CHMP) (link) for final approval.Further information about the CAT, EMA’s role in the regulation of ATMPs and guidelines specific to ATMPs is available on A combination ATMP includes 1 or more medical devices or active implantable medical devices in the product, as well as cells or a tissue component.
The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time.
EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants.Between July and end of September 2016, EMA released for public consultation a The consultation of the concept paper served as the basis for the revision of the guideline, which was carried out by an EU-wide group made up of experts from the national competent authorities who authorise clinical trials in the EU.
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The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group (GCP IWG), the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Advice on the regulatory routes is available using the MHRA and Human Tissues Authority (HTA) work closely together in this area.HTA and MHRA have agreed that the collection of blood as a starting material for an ATMP can be carried out under either a tissues and cells licence or a blood establishment licence. Data Monitoring Committees for Clinical Trial Sponsors, The Establishment and Operation of Clinical Trial - 03/2006 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials …
EMA will make available all comments received, both on the initial concept paper and on the revised guideline, in September 2017. EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants. It will take only 2 minutes to fill in.