🔒 ★ European Medicines Agency Pre-Authorisation Procedural Advice
Guidance on procedural advice for users of the centralised procedure by the European Medicines Agency.
High impact 20 min
Updated daily from FDA, EMA, ICH and leading publishers
The pharma industry's research library
Curated regulatory guidance, clinical analyses, and market reports. AI-summarized, editor-reviewed, instantly downloadable.
12whitepapers
8publishers
6regions
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Research Pulse
Aggregated from live regulatory feeds 12 Research reports In library
8 Publishers FDA, EMA, industry
3 Featured Editor picks
6 Gated downloads Lead-gen reports
Quick answer
NovaPharmaNews hosts 12 curated pharmaceutical whitepapers and industry reports from 8 publishers — FDA and EMA regulatory guidance, clinical analyses, manufacturing intelligence, and market research. 3 featured reports are editor-picked this week. Each landing page includes key takeaways, optional PDF download, and links to related drugs, companies, and pipeline data.
Methodology & data sources Publications & analysis Editorial policy
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12 results 🔒 ★ 
🔒 EFPIA report: economic impact of industry clinical trials across Europe
Industry clinical trials created €10.1 billion in direct GVA and €21.7 billion in total GVA across the EEA in 2025, accounting for indirect …
High impact 68 min
🔒 Efpia on AI Across the Medicines Lifecycle: Governance, GxP and Regulatory Policy Insights
AI governance across the medicines lifecycle requires attention to five critical stages: planning and design, data collection and processing…
High impact 48 min
🔒 IP News Bulletin for Japan and China, June 2026
China's NMPA issued Implementation Measures for Drug Trial Data Protection, introducing up to 6-year data exclusivity for innovative drugs.
High impact 20 min
Barriers and Facilitators to Use of Digital Health Tools by Healthcare Practitioners
This study identifies key barriers and facilitators impacting healthcare practitioners' use of digital health technologies during and before…
High impact 5 min
🔒 La Negoziazione del Prezzo dei Farmaci Oncologici in Italia
This whitepaper analyzes the market benchmark role in negotiating oncology drug prices in Italy, highlighting key implications for clinical …
High impact 8 min
Examining the Validity of External Controls Relative to Randomized Controls
This presentation discusses the validity of external controls in medical product development and their comparison to randomized controls.
High impact 5 min
Radiopharmaceuticals - EU-IN Horizon Scanning Report
This report outlines the current status, trends, and regulatory challenges in the field of radiopharmaceuticals in the EU.
High impact 5 min
Cytological Specimens in the Molecular Era of Metastatic Melanoma
This whitepaper discusses the role of cytological specimens in diagnosing metastatic melanoma and their implications for precision oncology.
High impact 5 min
🔒 This review discusses the 2024 revision of EU GMP Annex 1, focusing on contamination control and quality risk management in sterile manufact…
High impact 7 min
AESGP Position on Commission Proposal for Simplification of MDR
This position paper outlines AESGP's recommendations on simplifying medical device regulations in Europe.
High impact 5 min
Overview of Comments Received on ICH Q3E Guideline
This document summarizes comments on the ICH Q3E Guideline regarding extractables and leachables, focusing on regulatory and safety consider…
High impact 5 min
Frequently asked questions
What whitepapers does NovaPharmaNews publish?
Our research library curates FDA, EMA, and industry publisher PDFs — regulatory guidance, clinical analyses, manufacturing reports, and market intelligence. Each report includes an AI-summarized landing page with key takeaways and a gated PDF download.
How do I download a whitepaper?
Open any report page, scroll to the download form, and enter your work email. You receive instant PDF access and can opt in to weekly pharma intelligence updates. Downloads are free for healthcare professionals.
How do whitepapers connect to news and pipeline data?
Report pages link to related intelligence — company profiles, drug INN pages, clinical trials, pipeline programs, and topic hubs. Use the intelligence spokes on each page to explore the entity graph behind the research.
How often is the library updated?
New reports are ingested daily from leading publishers and regulatory sources. Featured picks highlight high-impact FDA, EMA, and industry research each week.