var _paq = window._paq = window._paq || []; /* tracker methods like "setCustomDimension" should be called before "trackPageView" */ _paq.push(['trackPageView']); _paq.push(['enableLinkTracking']); (function() { var u="https://rwrregs.matomo.cloud/"; _paq.push(['setTrackerUrl', u+'matomo.php']); _paq.push(['setSiteId', '1']); var d=document, g=d.createElement('script'), s=d.getElementsByTagName('script')[0]; g.async=true; g.data-privacy-src='//cdn.matomo.cloud/rwrregs.matomo.cloud/matomo.js'; s.parentNode.insertBefore(g,s); })();

Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

RWE 201 – THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

In our real world evidence (RWE) 201 series we have been exploring the regional regulatory and data access frameworks that have been implemented to support access to clinical experience data (real world data | RWD), which is crucial if we are to use this RWD to generate RWE.
 
The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.
 
The following posts provide more details and visual summaries:
 
•  EU – EU4Health Program: https://lnkd.in/dFkkfp8Y
•  EU – The European Health Data Space: https://lnkd.in/dVMFrvD2
•  EU – The Data Governance Act: https://lnkd.in/dhGW5euQ
•  EU – EMA’s 2025 Vision for RWE: https://lnkd.in/d-quNktH
•  EU – EMA RWE Framework to Support Regulatory Decision Making:
•  EU – EU’s Action Plan for Real-World Data (RWD) & RWE: https://lnkd.in/d4TwfXM7
•  EU – RWD/RWE is Embedded into the New EU Medicines Regulations: https://lnkd.in/dxEZ55AT

Share this story...

Real World Evidence (RWE) 201…THE END – A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU2023-12-08T14:58:47+00:00

Real World Evidence (RWE) 201 – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development

RWE 201 – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development

Australia has several real-world evidence (RWE) initiatives to support healthcare and drug development. The Therapeutic Goods Administration (TGA) has established a framework for the use of real-world data (RWD) and RWE in regulatory decision-making, which includes the use of data from electronic health records and disease registries [1]. Following the 2021 Review into the usage of RWE and patient-reported outcomes (PROs) in the regulation of medicines and medical devices, the TGA has been working on incorporating RWE and PROs into its regulatory processes [2][3][4].

Additionally, the Medicines Intelligence Centre of Research Excellence (MI-CRE) was established to generate timely research supporting the evidentiary needs of Australian medicines regulators and payers by accelerating the development and translation of RWE on medicines use and outcomes [4]. MI-CRE aims to equip the next generation of medicines researchers in Australia with the skills to co-create evidence with end-users [5].

Despite these initiatives, there are still challenges and gaps in Australia’s RWE landscape. A review on generating RWE on the quality use, benefits, and safety of medicines in Australia highlights the need for a roadmap to bolster Australia’s capacity to accelerate evidence development about the effectiveness, safety, and quality use of medicines in routine clinical care [6]. Robust RWE generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable healthcare and improve the health and well-being of all Australians [6].

References:

[1] https://globalforum.diaglobal.org/issue/may-2023/rwd-rwe-in-2023-regulatory-policy-world-tour/

[2] https://www.tga.gov.au/real-world-evidence-rwe-and-patient-reported-outcomes-pros

[3] https://www.tga.gov.au/sites/default/files/real-world-evidence-and-patient-reported-outcomes-in-the-regulatory-context.pdf

[4] https://www.sciencedirect.com/science/article/pii/S0149291822000170

[5] https://ijpds.org/article/view/1726

[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8707536/

Share this story...

Real World Evidence (RWE) 201 – Advancing Healthcare in Australia: Embracing Real-World Evidence and Data in Medicine Regulation and Development2023-12-08T14:49:27+00:00

Real World Evidence (RWE) 201 – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development

RWE 201 – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development

South Korea has several initiatives to support healthcare and drug development using real-world evidence (RWE). The country’s regulatory bodies, government organizations, industry and academia leaders, and patient groups have started discussions to develop draft guidance for integrating RWE with reimbursement and regulatory decisions [1][2].

The Ministry of Food and Drug Safety (MFDS) in South Korea has recently issued guidelines on the use of RWE in regulatory decision-making, with a focus on the use of real-world data (RWD) to support clinical trial design and post-market surveillance [3]. In June 2021, the MFDS published the Guideline for Medical Information Database Research, which focuses on utilizing RWE that analyzed RWD, such as national health insurance data and electronic medical records, for post-marketing safety studies [4].

Moreover, the Korea Comprehensive Plan for Drug Safety Management (2020-2024) anticipates that the MFDS will continue to build a local ecosystem to leverage innovative technology, including RWE, to support new drug development [4].

In addition to these initiatives, an increasing number of studies are using healthcare claims databases to generate RWE for the effectiveness and safety of clinical therapeutics in South Korea [5]. These databases provide a rich source of RWD, which can be used to generate RWE for potential risk and benefit assessments derived from sources other than randomized controlled trials (RCTs) [5].

In summary, South Korea is actively working on leveraging RWE to support healthcare and drug development, with a focus on integrating RWE into regulatory and reimbursement decisions, supporting clinical trial design, post-market surveillance, and safety studies.

References:

[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10405531/

[2] https://www.sciencedirect.com/science/article/pii/S0149291822000170

[3] https://globalforum.diaglobal.org/issue/may-2023/rwd-rwe-in-2023-regulatory-policy-world-tour/

[4] https://globalforum.diaglobal.org/issue/june-2022/real-world-evidence-regulatory-landscape-in-asia-pacific-australia-china-japan-south-korea-and-taiwan/

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272364/

Share this story...

Real World Evidence (RWE) 201 – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development2023-12-08T14:39:24+00:00

Real World Evidence (RWE) 201 – Taiwan: Integrating Real-World Evidence for Drug Development and Policy Making

RWE 201 – Taiwan: Integrating Real-World Evidence for Drug Development and Policy Making

 

Taiwan has several real-world evidence (RWE) initiatives to support healthcare and drug development. Over the past decade, RWE has been integrated into Taiwan’s national pharmacovigilance system, primarily using nationwide claims databases. Other sources of real-world data, such as national registries and large electronic hospital databases, have also become available recently [1]. The Taiwan Food and Drug Administration (TFDA) has published guidelines on the review of real-world data (RWD) and RWE-based applications to support and supervise new developments in this area [2].

One of the key data sources for RWE in Taiwan is the National Health Insurance Research Database (NHIRD), which covers more than 99.6% of the Taiwanese population[6]. The Ministry of Health and Welfare (MOHW) has established a Health and Welfare Data Center (HWDC) that centralizes the NHIRD and about 70 other health-related databases for data management and analysis[3]. This database has been used for various real-world studies, generating evidence to support clinical decisions and healthcare policy-making [3].

In summary, Taiwan has made significant progress in integrating RWE into its healthcare and drug development landscape, with the NHIRD being a major resource for generating RWE. However, further efforts are needed to improve procedural and methodological practices and to link different sources of real-world data [1].

References:

[1] https://pubmed.ncbi.nlm.nih.gov/32894792/

[2] https://ibmi.taiwan-healthcare.org/en/news_detail.php?REFDOCID=0qvwj80x7fj37zxv

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6509937/

Share this story...

Real World Evidence (RWE) 201 – Taiwan: Integrating Real-World Evidence for Drug Development and Policy Making2023-12-08T14:34:38+00:00

Real World Evidence (RWE) 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development

RWE 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development

 

Japan has several initiatives to support healthcare and drug development using real-world evidence (RWE). Pharmaceutical companies in Japan are increasingly using RWE to inform their decision-making, respond to requests from external stakeholders, and improve their therapies. They use advanced RWE analytics to identify previously unrecognized issues such as low treatment rates, late initiation, and the omission of large patient segments. This information can then be used to improve engagement with healthcare providers [1].

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has recognized the importance of using real-world data (RWD) for regulatory purposes. Discussions regarding the acceptability of RWE for regulatory submissions have already been initiated [2]. The PMDA and the Ministry of Health, Labour, and Welfare (MHLW) have worked to promote the utilization of RWD/RWE throughout a drug’s life cycle [3].

There are also specific projects aimed at promoting the use of RWE in Japan. For instance, the Clinical Innovation Network (CIN) project, led by the MHLW and promoted by the Japan Agency for Medical Research and Development (AMED), aims to revitalize the clinical development of new drugs and medical devices in Japan by utilizing patient registries and cohort studies [4][5].

However, there are challenges to the use of RWE in Japan, such as limited access to data, difficulty in linking databases, poor data quality, unclear guidance on the acceptability of RWD/RWE by regulators, and lack of decision criteria, standards, and guidelines for RWE development [4].

Despite these challenges, the use of RWE in Japan is growing, and efforts are being made to overcome these obstacles. For example, the Japanese affiliate of one multinational pharma company used RWE data to shed light on the treatment journey of over 50,000 patients [1]. Another example is Chugai, a pharmaceutical company in Japan, which has conducted an exploratory study of efficacy and safety using anonymized electronic medical record information with the National Cancer Center Japan [6].

References:

[1] https://www.mckinsey.com/industries/life-sciences/our-insights/advancing-real-world-evidence-for-pharmaceutical-companies-in-japan

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10182751/

[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9290512/

[4] https://link.springer.com/article/10.1007/s40801-021-00266-3

[5] https://www.frontiersin.org/articles/10.3389/fmed.2022.864960

[6] https://www.chugai-pharm.co.jp/english/profile/digital/real_world_data.html

[7] https://www.valuehealthregionalissues.com/article/S2212-1099(20)30494-5/fulltext

Share this story...

Real World Evidence (RWE) 201 – Revolutionizing Healthcare in Japan: The Rise of Real-World Evidence in Drug Development2023-12-08T14:31:09+00:00

Real World Evidence (RWE) 201 – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation

RWE 201 – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation

–  Zhong et al., Advancing the Development of Real-World Data for Healthcare Research in – – – China: https://bmjopen.bmj.com/content/12/7/e063139

– NMPA Guidelines on the Use of RWE to Support Drug Development: https://redica.com/wp-content/uploads/NMPA_-Attachment_-_Guiding-Principles-of-Real-World-Data-Used-to-Generate-Real-World-Evidence-Trial_.pdf

– Hainan Boao Lecheng International Medical Tourism Pilot Zone: https://www.cde.org.cn/main/news/viewInfoCommon/e3cd052e638876697399de962b7354a4

China is increasingly embracing the use of real-world evidence (RWE) in research and drug development. The systematic use of RWE to support drug regulatory decision-making is still in its infancy in China, but national drug regulatory authorities have begun applying RWE in the review and approval process. The application and development of real-world data (RWD) and RWE in drug regulatory decision-making have been vigorously promoted in China.

One of the ways China is using RWE is to support decisions about whether a drug should be included in the reimbursement list and whether it should be renewed. The Hainan Boao Lecheng international medical tourism pilot zone, known as the Hainan model, has been used to generate RWE to support regulatory approval without conducting a trial in China. This type of evidence could also be used to support reimbursement decisions to minimize delay to market entry.

However, there are challenges to the wider adoption of RWE in China. These include limited research capacity and the need for more researchers with in-depth understanding of methodologies, data, and healthcare settings in China. There are also regulatory hurdles, such as the need for approval from the Human Genetic Resource Administration of China (HGRAC) for studies using healthcare RWD, and cross border data transfer security assessments and licences.

Despite these challenges, there are signs of progress. For example, the province of Hainan has pioneered the use of RWE, including for drugs and medical devices that are new to China. The National Medical Products Administration (NMPA) of China has also published guidelines on the use of RWE in supporting drug review, indication expansion, post-approval evaluation, and research and development of traditional Chinese medicine.

In conclusion, while the use of RWE in China is still developing, it is gaining recognition and is being increasingly used in drug development research and regulatory decision-making. This trend is likely to continue as China seeks to improve its healthcare system and drug development processes.

Share this story...

Real World Evidence (RWE) 201 – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation2023-12-08T14:17:40+00:00

Real World Evidence (RWE) 201 – EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation

RWE 201 – EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation

Updated EMA Big Data Steering Group Workplan: https://www.ema.europa.eu/en/documents/work-programme/workplan-2023-2025-hma/ema-joint-big-data-steering-group_en.pdf

The Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) Big Data Steering Group workplan has been enhanced including work on national regulatory use cases for real-world evidence (RWE), intensified work on artificial intelligence (AI) and public consultation on patient experience data (PED).

The updated Big Data Steering Group (BDSG) workplan continues to evolve to integrate use of big data and data analytics in medicines regulation. he updated workplan contains the following key additions:

[1] Real-world evidence (RWE): DARWIN EU® will address use cases from national regulators and learnings from RWE pilots will be gathered and published.  Work on RWE guidance, at EU and international level, will be informed by public consultations and collaboration with international regulators under the umbrella of ICH will continue.

[2] Real World Data (RWD) quality considerations will be published following a public consultation.

[3] Engagement with patients’ organisations will intensify through a public consultation on Patient Experience Data (PED), dialogue on training needs, workshop on patient registries, a call to populate the metadata and RWD source catalogues with PED, and exploration of use cases to analyse PED to establish their role in regulatory decision-making process.

[4] Analysis of additional data types will be explored with the development of use cases for genomics data, the launch of a ‘proof of concept’ on non-clinical raw data analysis and discussion on Chemistry, Manufacturing and Controls (CMC) data analysis.

[5] Experimentation of advanced analytics, including AI, will continue and the first AI knowledge mining tool for core regulatory processes will be released to the EU regulatory network.

[6] The future European Medicines Regulatory Network data strategy will be developed to prepare for publication in 2025.

A full overview of the timeline can be found here: https://www.ema.europa.eu/en/documents/work-programme/workplan-2023-2025-hma/ema-joint-big-data-steering-group_en.pdf

Share this story...

Real World Evidence (RWE) 201 – EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation2023-12-08T14:14:24+00:00

Real World Evidence (RWE) 201 – Germany’s Draft Health Data Usage Act

RWE 201 – Germany’s Draft Health Data Usage Act

 

Draft Health Data Usage Act (GDNG): https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/gesundheitsdatennutzungsgesetz.html

BfArM Health Research Data Center: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Forschungsdatenzentrum/_node.html

In June 2023, the German Federal Ministry of Health publicized a draft Health Data Use Act (GDNG) as part of the government’s digitalization strategy for the health sector. The Act aims to facilitate the use of health data for research purposes, which could have positive implications for the pharmaceutical and medical device industry. The GDNG also seeks to prepare Germany for the European Health Data Space (EHDS).

The Act proposes to establish a central data access and coordination point to enable access to research data from various sources, such as existing silos like the cancer registry or health insurance data. The Health Research Data Center of the Federal Institute for Drugs and Medical Devices (BfArM) is expected to act as the intermediary between data users and data holders.

The Act also introduces an “Opt-Out” procedure for data sharing from the electronic patient record (ePA). From 2025, all insured patients will automatically receive a digital file unless they actively object. This procedure is expected to drive the exchange and use of health data and support targeted care.

However, the Act has sparked debates around data privacy and potential misuse. Critics argue that anonymized or pseudonymized data do not sufficiently protect against misuse, and there is a lack of legal obligation to encrypt the data. There are also concerns about the plans to transmit health data of millions of insured individuals not only to the EHDS but also to the USA.

On the other hand, proponents argue that the use of health data is essential for research, innovation, and medical care in the 21st century. They believe that the real ethical question is not how we can justify the use of health data, but rather, how we can justify not using it.

The Act is expected to come into force from January 2024. As the Act progresses, it will be crucial to balance the potential benefits of increased access to health data for research and innovation with the need to protect patient privacy and prevent data misuse.

Share this story...

Real World Evidence (RWE) 201 – Germany’s Draft Health Data Usage Act2023-12-08T10:40:44+00:00

RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU

RWR CONTEXT

The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.

OCTOBER 2023 – In our real world evidence (RWE) 201 series we have been exploring the regional regulatory and data access frameworks that have been implemented to support access to clinical experience data (real world data | RWD), which is crucial if we are to use this RWD to generate RWE.

Our RWE 201 posts can be accessed here: https://rwr-regs.com/rwe-201/ 

The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease prevention. The European Health Data Space is an effort to ensure secure access and exchange of health data across EU countries, enhancing healthcare quality and research. Complementing this, the Data Governance Act seeks to foster trust and facilitate data sharing for societal benefits. The European Medicines Agency (EMA)’s 2025 Vision for Real World Evidence (RWE) and the EMA RWE Framework to Support Regulatory Decision Making are pivotal in integrating real-world data (RWD) and RWE into regulatory processes, improving drug development and monitoring. The EU’s Action Plan for RWD & RWE further emphasizes the use of real-world healthcare data in policy and decision-making. Finally, the incorporation of RWD/RWE into the new EU Medicines Regulations marks a significant shift towards evidence-based, data-driven approaches in the pharmaceutical sector, aiming to enhance patient outcomes and healthcare efficiency across the EU.

The following posts provide more details and visual summaries:

  • EU – EU4Health Program [Link]
  • EU – The European Health Data Space [Link]
  • EU – The Data Governance Act [Link]
  • EU – EMA’s 2025 Vision for RWE [Link]
  • EU – EMA RWE Framework to Support Regulatory Decision Making [Link]
  • EU – EU’s Action Plan for Real-World Data (RWD) & RWE [Link]
  • EU – RWD/RWE is Embedded into the New EU Medicines Regulations [Link]
RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU2023-12-04T15:35:56+00:00

EU | Guidance on Medical Device Software (MDSW) intended to work in combination with hardware or hardware components

Please login to view this page.

EU | Guidance on Medical Device Software (MDSW) intended to work in combination with hardware or hardware components2023-12-04T15:01:09+00:00
Go to Top