🔒 ★ 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
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Curated regulatory guidance, clinical analyses, and market reports. AI-summarized, editor-reviewed, instantly downloadable.
17whitepapers
8publishers
6regions
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Aggregated from live regulatory feeds 17 Research reports In library
8 Publishers FDA, EMA, industry
3 Featured Editor picks
11 Gated downloads Lead-gen reports
Quick answer
NovaPharmaNews hosts 17 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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17 results 🔒 ★ 
🔒 EFPIA W.A.I.T Indicator 2026: 597-day waits
Full availability on public reimbursement lists stands at 28%, down from 29% in the 2024 study, indicating a declining trend in unrestricted…
High impact 144 min
🔒 EMA 2025 Annual Report Annexes: Committees, Opinions, and Governance
The document comprises 24 annexes documenting EMA committee memberships, 2025 scientific opinions, and regulatory decisions across human and…
Critical impact 374 min
🔒 Healthcare investment in Central and Eastern Europe: what pharma teams should know
CEE governments invested an average of 5.47% of GDP in healthcare in 2023, compared with 8.17% in the EU4 (Germany, France, Italy, Spain). T…
High impact 62 min
🔒 EFPIA on Harmonising Pharmaceutical Product Carbon Footprints with PAS 2090
Pharmaceutical product carbon footprint (PCF) and life cycle assessment (LCA) reporting currently lacks harmonised, sector-specific standard…
High impact 18 min
🔒 EFPIA analysis: biopharmaceutical strategies in 10 countries and what Europe can learn
Biotech and biopharma are now embedded in national security and competitiveness frameworks; policy support spans research, startups, manufac…
High impact 102 min
🔒 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
🔒 Japan and China Drug IP: Data Exclusivity and PTE
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
A BMJ Open multimethods study identifies three decision-making levels for digital health tool access: organizational, healthcare practitione…
High impact 5 min
🔒 La Negoziazione del Prezzo dei Farmaci Oncologici in Italia
Italy's 83% reimbursement rate for new cancer medicines (EMA approvals 2019-2022) exceeds the EU average and surpasses France (67%) and Spai…
High impact 8 min
Examining the Validity of External Controls Relative to Randomized Controls
EMA case studies in non-small cell lung cancer (NSCLC) and relapsed/refractory multiple myeloma (RRMM) showed external controls can replicat…
High impact 5 min
Radiopharmaceuticals - EU-IN Horizon Scanning Report
The EU has approved 20 radiopharmaceuticals. Five treat cancer. Fifteen aid diagnosis. Four work as theranostics for personalised care. See …
High impact 5 min
Cytological Specimens in the Molecular Era of Metastatic Melanoma
Ultrasound-guided FNAC detects 65% of sentinel node metastases with 99% specificity, providing a less invasive alternative to surgical biops…
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.