Global

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, 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.

A draft guideline from the World Health Organization intends to clarify regulatory expectations for the assessment of mAbs used for preventing and treating infectious diseases in health emergencies and to help with international harmonization efforts in this field.

The first document of a three-part series of ICH guidelines on conducting bioequivalence studies for orally administered immediate-release solid oral dosage forms has been issued for stakeholder consultation.

Ethiopia is the latest African country that the European Pharmacopoeia Commission has accepted as an observer.

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.

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.

A World Health Organization negotiating body has agreed to develop a “zero draft” of the proposed pandemic treaty for discussion at a meeting of WHO member states in February next year. But the international pharmaceutical industry has reiterated its concerns about some of the proposals being put forward.

Two documents published by the European Commission outline proposals to prepare for future health emergencies such as pandemics and the impact of antimicrobial resistance, with next-generation vaccines and novel or repurposed therapeutics high on the agenda.

Biodiversity footprinting may still be a new concept for pharmaceutical companies, but they need to put a clear supply chain strategy in place now, particularly as the COP 15 conference in December is expected to discuss mandatory reporting of biodiversity risks, says Luka Brown.

As Europe’s health emergency body HERA approaches its first anniversary, an unprecedented range of stakeholders including industry bodies will be meeting in December to discuss HERA’s achievements, while a separate event will showcase the next generation of vaccines for COVID-19 and other infections.