International
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 World Health Organization (WHO) has launched an initiative to highlight the pressing global need to reduce the impact of the pharmaceutical industry on the environment while maintaining high standards of safety and efficacy for products.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
Modernized good clinical practice principles finalized by the International Council for Harmonisation focus on fostering a quality culture, proactively designing quality into trials, identifying factors critical to trial quality, engaging interested parties, and using a proportionate risk-based approach.
Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.
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.
Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.
Clinical trial sponsors should strive to strike a balance between privacy and transparency at the very beginning of a trial to be successful, advises Certara’s Honz Slipka.
Two transparency experts share best practices for writing clinical study reports to protect patient privacy.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
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.
International regulators want developers of new mpox vaccines to consider alternatives to placebo-controlled studies when these are not feasible, such as the use of animal models and immunobridging studies.
Efforts to de-risk the pharma supply chain’s reliance on China likely will not completely disappear if the BIOSECURE proposal dies.
The International Coalition of Medicines Regulatory Authorities wants to see the rapid establishment and efficient conduct of platform clinical trials during public health emergencies.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
The International Council for Harmonisation is seeking input from IT vendors on what it will take to establish a state-of-the-art technology platform that drug sponsors can use to submit quality-related post authorization submissions for collaborative assessment by multiple regulatory authorities.
The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.
The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca’s director for data and AI policy says.
Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration’s Tala Fakhouri.
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.