Global News and Expert Analysis on
Pharma Policy and Regulation
Successfully Navigate Pharma Regulations and Policy
Today’s pharma regulatory environment is complex, with new approaches in an array ofareas including clinical trial design, expedited review pathways, digital tools, and innovative
reimbursement programs. Many of these policies offer new opportunities for pharma companies,
but staying on top of critical developments – and understanding them – is an enormous task.
Since 1939, Pink Sheet has been the leader in providing trusted insights on the news plus trend
analysis to help you navigate pharma policy – enabling you to understand what is happening today
and anticipate what will happen tomorrow.

Pink Sheet equips you with strategic information to bring products to market more quickly
and successfully, obtain reimbursement coverage and avoid compliance missteps in areas likemanufacturing and marketing that could take products off the market.

GLOBAL CONTENT FROM
TRUSTED EXPERTS
60+ journalists provide first-handcoverage of key events from locations
around the globe. Sources and readersalike trust our coverage as independent,
thorough and objective, thanks to our 80year track record of excellence.

CROSSING INDUSTRY SILOS
Coverage including innovator prescription
products, biosimilars and generic drugs, aswell as coverage across different regulatory
agencies allows us to identify cross-cutting
implications of policy. We connect up
regulatory developments and business impact.

INSIGHT BEYOND THE HEADLINES
Pink Sheet does much more than keep
you up to date. Our staff expertise andaccess to decision-makers and industry
leaders enable us to deliver coveragewith analysis of next steps, implications
and trends; and actionable insights onwhat developments could mean for yourbusiness.

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TRANSFORMING THE WAY YOU SEE THE WORLDCITELINE.COM

Must-know information

Exclusive features•	Opportunities from new approval pathways
and drug development incentive programs.

•	US FDA and EU Performance Trackers,
a data resource tracing products fromsubmission to approval and tracking areasof particular regulatory interest, such asdrugs designated as Breakthrough or PRIME
products.

•	Emerging regulatory topics, such as
biomarkers and digital tools.
•	New payer requirements at bothgovernment agencies and private insurers.
•	Regulatory agency organization andstaffing, and their impact on the drug
review process.
• Legislation affecting agency policies
and budgets.
•	Post-approval issues, including marketing
restrictions and safety surveillance.
•	Patent issues and litigation trends.
•	Drug approvals requirements at agencies
including US FDA, European Medicines
Agency and China National Medical Products
Administration, plus strategic takeaways
from precedent-setting approvals.

•	Drug Review Profiles, an in-depth lookbehind approval decisions with key insights
and lessons learned.
•	Global Guidance Tracker, a monthly updateof new rules and guidances with links toofficial documents.
•	Special focus areas: manufacturing,reimbursement, market access, andregional coverage.

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