The Agency consults on its proposals with EU Member States, the European Commission and stakeholders representing non-commercial and commercial clinical-trial sponsors, healthcare professionals and patient groups. EMA consulted on the draft functional specifications in October A total of 47 individuals and organisations submitted more than comments:.
EMA held a three-month consultation in on implementing the transparency rules. Over 80 different individuals and organisations submitted more than 1, comments:. Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.
Clinical Trials Regulation. Aims and key benefits of the Regulation. The Regulation will require: consistent rules for conducting clinical trials throughout the EU; information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available.
The key benefits of the Regulation include: harmonised electronic submission and assessment process for clinical trials conducted in multiple Member States; improved collaboration, information-sharing and decision-making between and within Member States; increased transparency of information on clinical trials ; highest standards of safety for all participants in EU clinical trials. How the Clinical Trials Information System will work.
EMA published the functional specifications for the EU portal and database available through CTIS to be audited in December , following a public consultation: Functional specifications for the EU portal and EU database to be audited The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial in a user-friendly way. Sponsor workspace A secure workspace will assist clinical trial sponsors in preparing and compiling data to submit to the system for assessment by Member States.
It will allow sponsors to: manage users and user roles within their organisations; compile clinical trial application dossiers for new and updated trials; cross-reference to product documents in other clinical trials ; upload documents for clinical trial application submission; receive alerts and notifications for ongoing trials; respond to requests for information and view deadlines; search and access clinical trials ; record clinical trial results.
Authority workspace A secure workspace will support the activities of Member States and the European Commission in overseeing clinical trials. It will allow Member States to: manage users and user roles within their organisations; view clinical trial application dossiers; manage tasks related to the assessment of clinical trials ; collaborate within and between Member States; receive alerts and notifications for ongoing trials; download documents submitted by clinical trial sponsors; record inspections of sites and clinical trials.
Public website Through the website, members of the public can access detailed information on all clinical trials conducted in the EU, in all official EU languages. The website will provide the following features: overview of clinical trial statistics; advanced search; download data and reports; site updates and announcements. Clinical Trials Information System development. CTIS is due to go live on 31 January EMA is working towards go-live, with the plan below.
List item. This regulation applies to both implantable medical devices and non-implantable medical devices. Although this new regulation is not fully effective until , certain articles are already in force. Below is a summary of the changes to the retention periods and new requirements that are included in these regulations.
If you are regulated by the European Union, be sure to update your retention periods for the relevant categories of records. If you need assistance in setting up or updating your retention schedule, contact Zasio. Disclaimer: The purpose of this post is to provide general education on Information Governance topics.
The statements are informational only and do not constitute legal advice. If you have specific questions regarding the application of the law to your business activities, you should seek the advice of your legal counsel.
Skip to content. Medical devices are products or equipment intended for a medical purpose. In the European Union EU they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. The conformity assessment usually involves an audit of the manufacturer's quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
EU Member States designate accredited notified bodies to conduct conformity assessments. In some cases, the notified body must seek a scientific opinion from EMA before issuing a CE certificate. The Medical Devices Regulation applies since 26 May , following a four-year transition period. Manufacturers must comply with the Regulation when placing new medical devices on the market. Some medicines are used in combination with a medical device, usually to enable the delivery of the medicine.
If the principal intended action is achieved by the medicine, it is considered a medicinal product that includes a medical device. EMA is responsible for evaluating the quality, safety and efficacy of marketing authorisation applications assessed through the centralised procedure , including the safety and performance of a medical device in relation to its use with a medicinal product.
The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July A medical device may contain an ancillary medicinal substance to support the proper functioning of the device.
These products fall under the medical devices legislation and must be CE marked. Examples of medical devices with an ancillary medicinal substance include:. Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the quality and safety of the ancillary substance if it is derived from human blood or human plasma , or if it is within the scope of the centralised procedure for the authorisation of medicines.
For other substances, the notified body can seek the opinion from a national competent authority or from EMA e. For information on the consultation procedure to seek an EMA scientific opinion, see Consultation procedure for ancillary medicinal substances in medical devices. A companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product , by identifying patients that are suitable or unsuitable for treatment.
Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA on the suitability of the companion diagnostic to the medicinal product concerned if:. For other substances, the notified body can seek the opinion from a national competent authority or EMA.
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