Innovation meetings are held by major EU Member States Competent Authorities (CA) to help organizations that are developing innovative medical devices (or using novel manufacturing processes) navigate the regulatory processes so they can progress their technologies.
Latest Glossary Definitions
In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.
The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.
Stochastic multi-state transition models. Transition between different states in the model are based upon pre-defined conditional probabilities that depend only on the current states (i.e. future evolution depends only on the current state, not the past states).
The protection of an approved medicine against competition from generic medicines that extends beyond the protection conferred by data exclusivity. During this period, applications for generics can be accepted and authorised, but the generic medicines cannot be placed on the market.
The 10-year period after the marketing authorisation of an orphan medicine when similar medicines for the same indication cannot be placed on the market.
Protocol assistance is the special form of scientific advice available for companies developing designated orphan medicines for rare diseases.
In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his
FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in the frame of clinical studies (i.e. Investigational Device Exemptions IDE), or premarket regulatory submissions (i.e. 510(k), De Novo, PMA etc.).
The distribution of a medicine from one Member State to another by a pharmaceutical company independently of the marketing authorization holder.