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Anti-Globalism Policy Cannot Stifle International Cooperation, US FDA’s Califf Says

The FDA commissioner said that supply chains will remain interconnected no matter how much nationalism dominates the political landscape, meaning international cooperation will still be necessary.

DIA Supply Chain

EMA & Health Canada Harmonize Anonymization Reporting For Clinical Trial Reports

Companies submitting clinical data for publication under the European Medicines Agency's Clinical Data Publication policy and Health Canada's Public Release of Clinical Information initiative can now provide a single anonymization report to both regulators. This report would explain the steps taken by sponsors to ensure the anonymized data poses a low risk of re-identification.

Europe Canada

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

BioPharmaceutical Neurology

Global Pharma Guidance Tracker – May 2024

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

A Success But Room For Improvement: Canada’s Conditional Approval Pathway

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

Canada Post Market Regulation & Studies

New Brazilian Law Shakes Up Clinical Trial Regulation

A new federal law aims to promote the conduct of trials and speed up access to innovative drugs in Brazil.

Brazil Clinical Trials

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

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

South America Colombia

Value Of Vaccines ‘Underestimated’ By Policymakers, Economic Researchers Find

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

International Europe

Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.

Egypt Clinical Trials

Brazil Pursues Regulatory Reliance Strategy For GMP Inspections

Brazil has listed 42 international regulatory bodies as equivalent authorities, including US FDA and the EU’s EMA.

South America Brazil

Global Pharma Guidance Tracker – April 2024

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

Swissmedic Gets New Grant For Regulatory Strengthening In LMICs

The Swiss agency says the aim of the agreement is to bring “high-quality, life-saving medicines to patients as quickly as possible.”

Middle East and Africa Regulation

EU Countries Offered Funding To Contribute to African Regulatory Strengthening

Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.

Middle East and Africa Regulation

Global Pharma Guidance Tracker – March 2024

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

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
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