Eric Wery, Vice President Market Access at VCLS conducted an Interview with Flora Georgio, Head of Sector HTA European Commission where she discusses her role and outlines how she supports interactions with numerous stakeholders.

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An inter-regulatory and stakeholder workshop on combination products, organised by TOPRA and RAPS, was held in Brussels in November 2018. Reported by Stéphanie Francard, Senior Regulatory  Scientist, VCLS, and Chris Wilson, Senior Director, Regulatory Science,...

There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT) designation, and the PRIority MEdicines (PRIME) scheme, as will be explained in this review. The expectations...

 

The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached on a transitional arrangement to soft en the impact of Brexit. The European Commission and the European Medicines Agency (EMA) have taken a...

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs).

The...

Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing costs, incremental benefit claims that extend over an extended time frame, restriction to centres...

By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and improved access to – high-quality drugs for the paediatric population. It is acknowledged that paediatric development remains a challenge...

The conference, organized by TOPRA in collaboration with the European Commission (EC), was the opportunity to hear about the EC’s 10-year review report to the European Parliament and the Council. The report provides an account of the paediatric regulation’s...

While individually rare, orphan diseases collectively are actually quite common, with an estimated 350 million sufferers worldwide. Since the introduction of the Orphan Drug Act in the US more than 30 years ago, followed by legislation in Japan in the 1990s, and the...

Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory...

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