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Set Alert for Global

Europe’s Proposed Chemical Ban Could Hit Many Thousands Of Global Marketing Authorizations

Drug manufacturing in the EU would grind to a halt in under three years if a proposal to restrict per- and polyfluoroalkyl substances in the European Economic Area is implemented in its current form, says industry group EFPIA.

Europe Drug Safety

WHO Seeks Feedback On Gaps In Current QA & GMP Guidelines

The World Health Organization has shortlisted over 30 quality assurance and good manufacturing practice guidelines that are over seven years old or need a major review.

International Guidance Documents

Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up?

A report comparing the health technology assessment methods used in nine European countries, Australia and Canada found that England has the most favorable reimbursement landscape for gene therapies – but outlined several areas for improvement across the board.

Europe International

Coronavirus Notebook: UN Pandemic Declaration Disappoints, Focus Turns To Draft WHO Treaty

The World Health Organization has published a “step-by-step guide” for countries wishing to increase their capacity for monitoring pathogens with pandemic and epidemic potential. The EU and the UK have cleared an updated version of Moderna’s COVID-19 vaccine Spikevax targeting the XBB.1.5 variant, while the EU has followed the US in approving Gilead’s Veklury as the first treatment for COVID-19 patients with mild-to-severe liver damage.

Europe International

Tackling AMR: OECD Says Greater Investment Needed In Later-Stage Drug R&D

Governments should increase financial resources for novel antimicrobial drug candidates in the later stages of development and tackle shortages of existing, underused antibiotics to combat antimicrobial resistance, says a new report from the OECD.

International Europe

Global Pharma Guidance Tracker – August 2023

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

Firms Look To Upgrade Aseptic Processing Lines As EU GMP Annex 1 Revision Takes Effect Globally

Sterile drug manufacturers get one year to comply with most revisions in updated EU, PIC/S and WHO GMP Annex 1 guideline. PDA survey hints at scale of challenge facing firms that still use traditional open filling lines, a practice expected to end under the Annex 1 revisions.

Manufacturing Drug Approval Standards

Quotable: Top Experts On Policy Hot Topics

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

International Europe

Coronavirus Notebook: EMA OKs Updated Cominarty Vaccine, UK Brings Forward Vaccination Campaign Amid Spread Of BA.2.86 Strain

The World Health Organization’s C-TAP has signed new COVID-19 vaccine licensing deals with Medigen Vaccine Biologics of Taiwan and a Spanish research body, while the WHO and UNICEF say overall immunization rates are rebounding after the pandemic backslide, but not in all countries equally.

Europe International

How AI Can Help Reduce Vaccine R&D From A Year To ‘A Matter Of Weeks’

From rapidly identifying antigenic targets to automating clinical trials, AI has an important role to play in cutting vaccine development time down to 100 days, says Melanie Saville, executive director of R&D at CEPI.

Europe International

How To Use The UK’s New International Recognition Pathway For Drug Approvals

Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.

United Kingdom International

New Collaborative Initiative To Deliver Tailored Support For RCTs In Low Resource Settings

Clinical trial networks around the world have teamed up to promote good randomized control trials in low- and middle-income countries. They plan to focus on multiple health challenges and diverse contexts.

International Clinical Trials

Should Pharma Firms Cover CDx Costs For Precision Cancer Drugs?

Significant financial reward awaits drugmakers that invest more in companion diagnostics during the development and marketing of precision cancer drugs, says Peter Keeling, CEO of Diaceutics – but Novartis warns that relying on pharma firms to fund these tests is unsustainable.

Europe International

Coronavirus Notebook: WHO Issues New Recommendations On Access To COVID-19 Products Amid Spread Of New EG.5 Variant

The UK is extending flexibilities that were introduced to ensure the supply and availability of COVID-19 and flu vaccines and has published its autumn vaccination schedule. Novavax expects to have its vaccine against the XBB strain of the virus ready by the end of September, while UK firm Infex is planning to begin clinical trials with a rival to Pfizer’s Paxlovid.

International Europe

WHO Meeting Reveals Differences Over Sharing Of Genomic Data In Public Health Crises

Members of the WHO’s working group on the International Health Regulations met for the fourth time last month to discuss proposed amendments to “important and substantive areas” of the IHR.

International Policy

‘Positive & Productive’ – US, EU Regulators On First Collaborative CMC Change Assessment

An application to add new manufacturing and quality control sites for a oncology biologic was approved in the US and the EU on the same day, a move that was said to be “a significant accomplishment” in aligning the regulators in each region on the assessment process and timeline.

Post Market Regulation & Studies Manufacturing
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