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Global Pharma Guidance Tracker – July 2022

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.

Guidance Documents Regulation

Global Regulators Join Hands To Boost RWE Use In Decision-Making

Existing challenges to using real-world evidence such as heterogeneous data sources around the world and the various governance models for data sharing and access will need to be addressed.

Real-World Evidence International

Global Pharma Guidance Tracker – June 2022

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.

Guidance Documents Regulation

US FDA Pursuing Two-Track Approach To Regulatory Convergence For Cell and Gene Therapies

Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.

Gene Therapy Regenerative Medicine

AMR Industry Alliance Publishes Manufacturing Standard

The AMR Industry Alliance has formalized its years-old Common Antibiotic Manufacturing Framework by publishing an antibiotic manufacturing standard, in what it terms a “groundbreaking step” in the drive for responsible manufacturing.

Manufacturing Safety

International Regulators Plan Roadmap For Collaborative RWE Studies

Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.

Coronavirus COVID-19 International

WTO Decision On Access To COVID-19 Vaccines: A Waiver In Name Only?

R&D-based companies have denounced what they see as a dangerous and unjustified attack on intellectual property after the World Trade Organization’s ministerial conference finally adopted a decision on an IP waiver for COVID-19 vaccines. NGOs, by contrast, say the decision amounts to little more than a limited exception to existing rules on the compulsory licensing of medicines.

International Coronavirus COVID-19

Coronavirus Notebook: Adapted Comirnaty Vaccine Under EU Review, Sanofi & GSK Laud Next-Gen Booster

Valneva expects its vaccine candidate to be approved this month. Meanwhile, the core functions of the UK’s Vaccine Taskforce are to be transferred to the UK Health Security Agency and the Office for Life Sciences.

Europe International

England: Shionogi And Pfizer Ink ‘World First’ Payment Model Deal For Antibiotics

Shionogi and Pfizer have formally agreed to a scheme that offers companies a new and sustainable payment model for innovating in antibiotics.

Europe International

WHO Recommends Three Vaccines For Use Against Monkeypox

With limited supplies of vaccines available, manufacturers are being asked to provide the World Health Organization with their smallpox and monkeypox vaccine research plans, existing stocks of vaccine, and current production capacity.

International Vaccines

Monkeypox: WHO Advises Antiviral Use In Trials Or Expanded Access Programs

With more than 1,200 confirmed cases of monkeypox in 28 non-endemic countries and disease incidence also rising in Africa, the WHO and the US CDC have each updated their guidance on the use of antiviral products. The US has just ordered 500,000 more doses of Bavarian Nordic's smallpox vaccine, Jynneos.

International United States

Industry Braces For More Pressure On IP For COVID-19 Products

The controversial “TRIPS waiver” is high on the agenda of the World Trade Organization’s upcoming ministerial conference, while a working group of the World Health Organization is drawing up a draft pandemic treaty that includes proposals to weaken IP on pandemic countermeasures.

International Coronavirus COVID-19
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