Global

The AAM has confirmed the departure of three executives, one of whom had also been serving as chair of the IGBA. As a result, the global generics industry association has brought in a new interim chair, at the same time as the head of one of the industry’s largest players has joined its CEO Advisory Committee.

The International Pharmaceutical Regulators Programme explains how manufacturers of cell and gene therapy products can assess and mitigate the potential risks associated with product raw materials.

Although estimands are a great tool for clarifying the treatment effects that are being investigated in a clinical trial, existing registries are not well suited for their public disclosure. Industry-wide guidance can help sponsors using different approaches. 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Measures to relax intellectual property protections are put forward in the “zero draft” of the World Health Organization's future pandemic treaty as well as in proposed amendments to the International Health Regulations, which describe how countries can prepare for and respond to health emergencies.

Alongside its ongoing biennial update of the essential medicines lists, the World Health Organization has carried out a review of the age-appropriateness of formulations on the list of medicines for children, in collaboration with the Global Accelerator for Paediatric Formulations (GAP-f).

As stakeholders in the US pharmaceutical distribution chain prepare to coordinate against suspect drugs, the world’s leading inspectorates collaborate on good distribution practices.

This second segment of a two-part Pink Sheet article on decentralized clinical trials looks at ensuring that staff at study sites are on onboard to support fast-paced change in this field, how regulatory guidance can help tackle hesitancy, and the need to transparently track such studies.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

The remarkable shift towards decentralized clinical trials in the last three years is a testament to how this patient-centric approach of doing research has the potential to solve multiple issues such as time, cost and low participation rates. In this first segment of a two-part article, the Pink Sheet looks at how innovation in this sector has just begun and we can expect more action ahead. 

The WHO’s proposed “TB Vaccine Accelerator council” will focus on the need for firm political and funding commitments, drawing on the high-level coordination that helped in the rapid development of COVID-19 vaccines.

A new WHO technical advisory group will help deliver the ambitions of the World Health Assembly’s 2022 resolution to strengthen global coordination on how clinical trials are conducted, evaluated and reported.