The “Condition” is typically a recognised distinct disease or syndrome that is the subject of a paediatric investigation plan (PIP) and/or waiver application required for most new, and some authorised, medicinal products in the EU. Its scope defines the disease(s)...

DIA Europe 2019 was held this year in Vienna, Austria. Speakers included national regulators, together with representatives from health technology assessment (HTA) bodies, patient advocacy groups, and other critical stakeholders. Presentations covered the entire...

Antimicrobial resistance (AMR) is the ability developed by bacteria, viruses, parasites or fungi to fight and block the effect of antimicrobials including antibiotics, antivirals and antiparasitics that were developed to kill or control their growth. AMR is a global...

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...

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