Global

The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.

A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.

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.

Robust regulatory systems with effective approval pathways and surveillance mechanisms to ensure continuity in clinical research, manufacturing and supply are needed to prepare for current and future health threats, says industry.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

The body that is steering the talks on a future pandemic treaty says it wants to focus on areas where consensus has been reached in order to maximize the chances of agreement by the end of May.

A procedure used to accelerate the approval of COVID-19 products during the pandemic is to be applied to all medicines using “synchronized and parallel, but otherwise entirely independent, processes,” the World Health Organization says.

Thomas Cueni is stepping down after seven years at the helm of the International Federation of Pharmaceutical Manufacturers and Associations. In an interview with the Pink Sheet ahead of his retirement, he reflects on the proposed pandemic treaty, what still needs to be done to ensure equitable access to medicines, the importance of tackling AMR, moves towards regulatory reliance – and what his post-IFPMA life might look like. 

Global regulators have yet to develop hard and fast rules for the use of artificial intelligence in drug development. Until they do, pharma companies should be guided by transparency and best practice principles when preparing submissions, a consultant says.

VeriSIM uses generative AI for questions such as changing a drug molecule’s chemistry and machine learning to better predict potential biological implications, says CEO Jo Varshney.

Health technology assessment bodies must strike a fine balance between standardizing their real-world evidence frameworks with those of other countries and tailoring them to meet population-specific needs, an expert tells England’s NICE.

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.

Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.

As talks restart this week on a future pandemic accord, the international drug industry body, the IFPMA, has reiterated its concerns over the negotiating text, saying some measures could “severely hinder responses to future pandemics.”

A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.

All new classes of antimicrobials for human use will fall within the World Health Organization’s highest criticality category under its latest guidance on preventing antimicrobial resistance.