Répertoire des programmes destinés à améliorer la santé dans le monde – Sélection de programmes e-santé et m-santé

External study 21 Jun 2024

The Value of Reference Agency Assessment Reports in Enabling Regulatory Reliance

Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was reviewed by the reference NRA, provides a rationale for decision making and promotes confidence and trust. The Centre for Innovation in Regulatory Science (CIRS) has published...

Pharmaceutical trade associations welcome latest announcement of largest number of regulatory agencies recognized under the WHO Listed Authorities Framework

On 21 May, pharmaceutical trade associations at international, European and US-level have welcomed the recognition of the European Medicines Regulatory Network (EMRN) and the United States Food and Drug Administration (FDA) as WHO Listed Authorities, as well as the expanded scope of functions of the Health Sciences Authority (HSA) of Singapore.

How we are contributing to global pharmaceutical standards

The evolving global pharmaceutical regulatory environment and the increasing interest of new countries in joining the ICH highlights the importance of maintaining consistent interpretation and implementation of ICH guidelines among industry and regulatory authorities worldwide. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), along with other ICH Members and Observers, has an important role...