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Global Pharma Guidance Tracker – December 2021

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

Point-Of-Care Manufacturing Successfully Treats B-Cell Cancers; How Will FDA Regulate It?

In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.

Manufacturing Quality

ICH Q9 Revision Published For Public Comment

ICH Q9 draft published for public consultation; changes focus on addressing subjectivity in quality risk management and managing risk for supply chains, among other topics.

Manufacturing Quality

Global Pharma Guidance Tracker – November 2021

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

ICMRA Review Finds Remote Alternatives Could Complement Onsite Inspections, Not Replace Them

Stance echoes US FDA’s view that remote alternatives should be “supplemental tools” to support in-person inspections.

Manufacturing Compliance

Industry Impacts Of COVID-19: Are Vaccine Mandates A Legal Solution?

The coronavirus pandemic is still raging but it is clear that higher vaccination rates worldwide will help the life sciences sector return to a semblance of normality. Lincoln Tsang, Julie Kvedar, and William Radcliffe of Ropes & Gray LLP consider the impact of the COVID-19 pandemic on the industry and the legal issues raised by mandatory vaccination in certain key geographical regions.

Legal Issues Coronavirus COVID-19

Achieving A Resilient Flu Vaccine Supply Chain Requires Retooling Most Of The Links

Expert panel draws lessons from COVID-19 in pressing for new manufacturing technologies, greater global coordination, more resilient supply chains and trained vaccine plant workers ready to “parachute” into the next outbreak.

Vaccines Manufacturing

Coronavirus Notebook: EMA OKs Roche's Tocilizumab For Severe COVID-19, Bavarian Nordic Reports ‘Positive’ Booster Results

The European Commission is to replace its COVID-19 vaccine export authorization system with a monitoring scheme, and the European Medicines Agency has confirmed the risk of myocarditis and pericarditis with the mRNA vaccines. The WHO and other bodies have called for better vaccine donation practices in Africa.

Europe International

Pandemic Treaty Could Have IP & Other Implications For Pharma

Equitable access to pandemic medicines and vaccines will be at the core of the WHO’s future global pandemic treaty. Exactly what this will mean for the pharmaceutical industry remains to be seen, but it is likely that companies wanting access to virus samples and other materials will need to agree to benefit sharing in the form of IP and technology transfer.

International Coronavirus COVID-19

ICH Makes Progress On Tackling Safety Data ‘Overload’

Changes to an ICH guideline could help drug companies that are being deluged with post-approval safety information to cut down on noisy, low-value data.

Safety International

Coronavirus Notebook: Molnupiravir EU Approval Likely By Year End, Special CHMP Session Due On Comirnaty in 5 to 11-year-olds

The EMA is assessing the Janssen vaccine as a booster, and Switzerland is evaluating the use of the Pfizer/BioNTech and Moderna COVID-19 vaccines in younger age groups. The WHO has announced the first voluntary global license on a COVID-19 antibody detection technology.

Europe Switzerland

Voluntary Limits On Antibacterial Discharges Increase As Fear Of Resistance Grows

Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?

Manufacturing Compliance
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