How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Policy 0070 is a ground-breaking initiative and the European Medicines Agency (EMA) represents the first agency on a global level that will grant access to clinical trial data on such a large scale. With the requirements for all non-Covid products expected to restart in 2023, there is preparation required for qualifying submissions – which include new marketing authorization applications (MAAs) and clinical variations.
Related Insights
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Related Insights
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Webinar
Assessing appropriate use of ECAs in clinical trials
May 28, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023