At the end of 2017, as required by Italian Law No. 232/2016, AIFA approved new criteria for the classification of a drug as innovative, the assessment procedures and the criteria to maintain the qualification of “innovative”. The criteria identified by AIFA are: 1) Therapeutic need: to be considered “innovative”, the therapeutic need can be classified…

To commercialize and take a drug to market, pharmaceutical companies are subject to stringent regulations that aim to protect the patients. This puts pressure on Sponsors to respect complex rules and regulate the entire “life cycle” of a drug – from development to authorization and post-market surveillance.During the last years, a lot of drug regulations came into effect in…

In November 2017, the European Commission published a set of new guidelines on Good Manufacturing Practices (GMP) specific to advanced therapy medicinal products (ATMPs).  Below, seQure Life Sciences created a summary about the new New Guidelines on Good Manufacturing pratices for advanced therapies: To download our infographic, click here. seQure is a niche services provider operating in the Life Sciences…

The new ICH GCP E6(R2) addendum came into effect from June 14, 2017. The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the European Medicines Agency (EMA). Previously, these guidelines were optional and the addendum now makes mandatory some activities related to Quality Management. With…

As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002…

©2017 - seQure - All Right Reserved - Privacy Policy - Cookie Policy