Acceptance of stakeholder comments during EMA scientific guideline public consultations: Legitimacy of the quadruple helix model of innovation.

Aims: Guidelines establish a framework for how therapeutics and vaccines are developed, assessed and approved. They influence which innovations are likely to be approved in the European Union (EU), and thus, they have an impact on the pipeline decisions taken by research-based industry. This study analyses the level of acceptance for changes suggested by stakeholders within the authoring groups at the European Medicines Agency (EMA).

Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation.

Background: The oral explanation (OE) is a critical event during new marketing authorisation procedures in the European Union (EU). The primary objective of the present study was to investigate how many procedures, having an OE in front of the Committee for Medicinal Products for Human Use (CHMP), resulted in a regulatory approval for oncology products.

Methods: Procedures for new marketing authorisation applications (MAAs) and Type II variations (new indication) for oncology products with at least one OE (with or without a Scientific Advisory Group (SAG) meeting) and for which the outcome took place between 31 January 2016 to 31 January 2020 were included in the analysis.

Regional Differences During the ICH Regulatory Consultation Process Between the EU, US, and Japan.

With the globalization of the pharmaceutical industry, initiatives like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have emerged to tackle the increasingly complex regulatory environment and challenges. During the development of harmonised guidelines, regional regulatory agencies (European Medicines Agency, US Food and Drug Administration, and Japan's Ministry of Health, Labour and Welfare) collect comments of all their respective stakeholders through public consultation processes. This process should allow for extensive and comprehensive expert input.

[Five years of European regulation on medication use in children: what has been achieved?].

It is not known if many existing medications can safely be used in children. For this reason the EU Paediatric Regulation came into force in 2007. When new medications are developed, pharmaceutical companies are obliged to produce a plan to research their use in children which must be approved by the regulatory authorities.