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Article ; Online: Pregnancy and medicines: time for paradigm change.

Saint-Raymond, Agnes / Mofenson, Lynne M

Journal of the International AIDS Society

2022 Volume 25 Suppl 2, Page(s) e25906

MeSH term(s)	Female ; HIV Infections ; Humans ; Pregnancy
Language	English
Publishing date	2022-07-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2467110-1
ISSN	1758-2652 ; 1758-2652
ISSN (online)	1758-2652
ISSN	1758-2652
DOI	10.1002/jia2.25906
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Teixeira, Tania / Kweder, Sandra L / Saint-Raymond, Agnes

Clinical pharmacology and therapeutics

2019 Volume 107, Issue 3, Page(s) 507–513

Abstract: There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here, we present the reality of the collaboration between the European Medicines Agency (EMA) and the US Food and Drug ... ...

Abstract	There is talk of regulatory collaboration worldwide to protect public health and allow patients timely access to medicines. Here, we present the reality of the collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This takes the form of near daily interactions, which may be less known outside of regulatory agencies. We present a review of what we call clusters, which involve the EMA, the FDA, and many other agencies under the umbrella of confidentiality arrangements. Through a survey of participants, we identified about 30 clusters of variable composition; these allow for the exchange of information and discussion among experts of applying regulatory science to common challenges in global drug development at every phase of its lifecycle and facilitate global medicines development.
MeSH term(s)	Drug Approval/legislation & jurisprudence ; Drug Development/legislation & jurisprudence ; Europe ; Government Agencies/organization & administration ; Humans ; International Cooperation ; United States ; United States Food and Drug Administration
Language	English
Publishing date	2019-10-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1617
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Article ; Online: WHO collaborative registration procedure using stringent regulatory authorities' medicine evaluation: reliance in action?

Vaz, Alexandra / Roldão Santos, Mariana / Gwaza, Luther / Mezquita González, Elena / Pajewska Lewandowska, Magdalena / Azatyan, Samvel / Saint-Raymond, Agnès

Expert review of clinical pharmacology

2022 Volume 15, Issue 1, Page(s) 11–17

Abstract: Introduction: The regulatory approval of medical products in countries with limited regulatory resources can be lengthy, which often compromises patients' timely access to much-needed medicines. To improve the efficiency of regulatory systems, reliance ... ...

Abstract	Introduction: The regulatory approval of medical products in countries with limited regulatory resources can be lengthy, which often compromises patients' timely access to much-needed medicines. To improve the efficiency of regulatory systems, reliance is being used. Reliance allows an authority to leverage the work performed by other authorities, such as scientific evaluations, to decide on medical products approval within their jurisdiction. This reduces duplication of regulatory efforts, resources and time, while maintaining national sovereignty. Areas covered: This article analyzes the outcomes and stakeholders' experience of using medicines assessments performed by Stringent Regulatory Authorities (SRA) in the Collaborative Registration Procedures (CRP). Since its establishment in 2015, 59 approvals were granted to 16 medicines in 23 countries through SRA CRP. Results show that the procedure is delivering on the intended benefits of access and speed, with long-term positive impact for resource-limited countries. The article concludes with recommendations on the need for guidance on management of post-approval changes, wider promotion of the procedure, and increased collaboration between authorities. Expert opinion: The SRA CRP provides a mechanism for the use of reliance by strengthening communication and promoting the exchange of information among regulators. This fosters faster regulatory approvals and, consequently, earlier access to medicines.
MeSH term(s)	Humans ; World Health Organization
Language	English
Publishing date	2022-02-12
Publishing country	England
Document type	Journal Article
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1080/17512433.2022.2037419
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Article ; Online: Reliance is key to effective access and oversight of medical products in case of public health emergencies.

Saint-Raymond, Agnes / Valentin, Marie / Nakashima, Nobumasa / Orphanos, Nick / Santos, Gustavo / Balkamos, Georgios / Azatyan, Samvel

Expert review of clinical pharmacology

2022 Volume 15, Issue 7, Page(s) 805–810

Abstract: Introduction: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, ... ...

Abstract	Introduction: Responding to new threats and public health emergencies (PHE) creates serious challenges to regulators. The pandemic due to SARS-CoV-2 has been the catalyzer for change in global and local regulatory practices. Intensified collaboration, rapid and coordinated actions, and reliance mechanisms were key elements of the regulators' response to COVID-19 for all regulatory functions. Areas covered: This article presents how collaboration and reliance among regulators were crucial tools for the regulatory responses to COVID-19, describes the reliance approaches for authorization of COVID-19 vaccines and other commodities, and the importance of reliance for other regulatory functions to avoid duplication and save resources where possible. This article also presents the results of a follow-up survey of reliance approaches in case of public health emergencies conducted between the International Pharmaceutical Regulators Programme (IPRP) members and discusses the forward-looking potential of reliance, analyzing the journey from theoretical concepts to real-life implementation. Expert opinion: Regulatory reliance is an essential tool for regulators to act quickly and collectively in times of public health emergencies. Reliance approaches facilitate regulatory approvals and allow a more efficient use of resources, ultimately serving patients by facilitating earlier access to quality assured, safe and effective medicines.
MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Emergencies ; Humans ; Public Health ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-08-09
Publishing country	England
Document type	Journal Article
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1080/17512433.2022.2088503
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Article ; Online: Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems.

Saint-Raymond, A / Sato, J / Kishioka, Y / Teixeira, T / Hasslboeck, C / Kweder, S L

Expert review of clinical pharmacology

2020 Volume 13, Issue 10, Page(s) 1095–1101

Abstract: Introduction: There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020.: Areas covered: We compare the first regulatory approvals for remdesivir, through emergency pathways available to three of the main ... ...

Abstract	Introduction: There were no formal regulatory approvals for antivirals for the COVID-19 pandemic as of June 2020. Areas covered: We compare the first regulatory approvals for remdesivir, through emergency pathways available to three of the main regulators in the world, the U.S., Japan, and the EU. We look at the data supporting the decisions and how authorities exchanged information and collaborated to speed up approvals. Based only on topline data available as of 29 April 2020, regulators granted approvals to remdesivir based on very limited but robust data and waiting for more safety and efficacy data. This included the Emergency Use Authorization in the U.S. on 1 May, the Special Approval for Emergency in Japan on 7 May, and Compassionate Use (3 April) followed by a Conditional Marketing Authorization in Europe (Opinion 25th June, Decision (3 July)). Expert opinion: While the regulatory approvals were clearly based on evidence, regulators used agile methods to speed up approval, and make the first antiviral with reliable data available to patients in their constituencies in a very short time frame. More data and wider patient access are still necessary for this product, and more treatments are needed for patients affected by COVID-19.
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/therapeutic use ; Alanine/analogs & derivatives ; Alanine/therapeutic use ; Antiviral Agents/therapeutic use ; Betacoronavirus ; COVID-19 ; Compassionate Use Trials ; Coronavirus Infections/drug therapy ; Drug Approval ; Emergency Medical Services ; European Union ; Humans ; Japan ; Pandemics ; Pneumonia, Viral/drug therapy ; SARS-CoV-2 ; United States
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-09-29
Publishing country	England
Document type	Comparative Study ; Journal Article ; Review
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1080/17512433.2020.1821650
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Article ; Online: Global Cancer Drug Development-A Report From the 2022 Accelerating Anticancer Agent Development and Validation Meeting.

Wilson, Brooke E / Sullivan, Richard / Peto, Richard / Abubakar, Bello / Booth, Christopher / Werutsky, Gustavo / Adams, Cary / Saint-Raymond, Agnes / Fleming, Thomas R / Lyerly, Kim / Gralow, Julie R

JCO global oncology

2023 Volume 9, Page(s) e2300294

Abstract: Rapidly expanding systemic treatment options, combined with improved screening, diagnostic, surgical, and radiotherapy techniques, have led to improved survival outcomes for many cancers over time. However, these overall survival gains have ... ...

Abstract	Rapidly expanding systemic treatment options, combined with improved screening, diagnostic, surgical, and radiotherapy techniques, have led to improved survival outcomes for many cancers over time. However, these overall survival gains have disproportionately benefited patients in high-income countries, whereas patients in low- and middle-income countries (LMICs) continue to experience challenges in accessing timely and guideline concordant care. In September 2022, the Accelerating Anticancer Agent Development and Validation workshop was held, focusing on global cancer drug development. Panelists discussed key barriers such as the lack of diagnostic services and human resources, drug accessibility and affordability, lack of research infrastructure, and regulatory and authorization challenges, with a particular focus on Africa and Latin America. Potential opportunities to improve access and affordability were reviewed, such as the importance of prioritizing investments in diagnostics, investing health infrastructure and work force planning, coordinated drug procurement efforts and streamlined regulatory processing, incentivized pricing through regulatory change, and the importance of developing and promoting clinical trials that can answer relevant clinical questions for patients in LMICs. As a cancer community, we must continue to advocate for and work toward equitable access to high-quality interventions for patients, regardless of their geographical location.
MeSH term(s)	Humans ; Developing Countries ; Neoplasms/drug therapy ; Neoplasms/radiotherapy ; Income ; Antineoplastic Agents/therapeutic use ; Drug Development
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2023-11-10
Publishing country	United States
Document type	Journal Article
ISSN	2687-8941
ISSN (online)	2687-8941
DOI	10.1200/GO.23.00294
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Article ; Online: What to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016.

Kondo, Hideyuki / Saint-Raymond, Agnès / Yasuda, Naoyuki

Therapeutic innovation & regulatory science

2017 Volume 52, Issue 2, Page(s) 214–219

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new ... ...

Abstract	The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the European Medicines Agency (EMA) have a long-standing experience of reviews of new medicines, and they meet their target pre-market review periods. In FY 2016 / 2016, 112 and 83 new medicines were approved in Japan and EU, respectively. Out of these medicines, 41 and 27 medicines containing new active ingredients were approved with total pre-market review periods of 209 days and 428 days in Japan and EU, respectively. Approximately one-third of these medicines were reviewed by the Agencies in close timing, within 1 year between pre-market review applications in Japan and in EU. Taking into account the increasing number of global clinical trials and constant number of consultations or scientific advice related to global clinical trials in Japan, it is clear that the importance of the continuous, collaborative relationship between EMA and PMDA is more and more crucial, as it does facilitate close and timely exchange of information and opinions on products and technologies under development. There already are effective collaborative frameworks between PMDA and EMA in addition to daily communication, and our findings support the development and best use of regulatory tools such as consultation services and scientific advice/protocol assistance for the benefit of the pharmaceutical industry but mostly of patients.
MeSH term(s)	Cooperative Behavior ; Drug Approval ; European Union ; Government Agencies ; Humans ; Japan
Language	English
Publishing date	2017-07-21
Publishing country	Switzerland
Document type	Comparative Study ; Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1177/2168479017720248
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Article ; Online: The European Medicines Agency facilitates access to medicines in low- and middle-income countries.

Cavaller Bellaubi, Maria / Harvey Allchurch, Martin / Lagalice, Clement / Saint-Raymond, Agnes

Expert review of clinical pharmacology

2020 Volume 13, Issue 3, Page(s) 321–325

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	Developing Countries ; Drug Approval/legislation & jurisprudence ; European Union ; Global Health ; Government Agencies/organization & administration ; Health Services Accessibility/legislation & jurisprudence ; Humans ; Pharmaceutical Preparations/supply & distribution ; World Health Organization
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2020-02-13
Publishing country	England
Document type	Journal Article
ISSN	1751-2441
ISSN (online)	1751-2441
DOI	10.1080/17512433.2020.1724782
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Medicine safety in pregnancy and ambitions for the EU medicine regulatory framework.

Saint-Raymond, A / de Vries, C S

Clinical pharmacology and therapeutics

2016 Volume 100, Issue 1, Page(s) 21–23

Abstract: Is the European Union (EU) regulatory framework concerning pregnant women and women at risk of becoming pregnant fit for the purpose? This article discusses improvements in how medicines should be developed and monitored for safe and effective use by ... ...

Abstract	Is the European Union (EU) regulatory framework concerning pregnant women and women at risk of becoming pregnant fit for the purpose? This article discusses improvements in how medicines should be developed and monitored for safe and effective use by pregnant women and women at risk of becoming pregnant.
MeSH term(s)	Drug Design ; Drug and Narcotic Control ; Drug-Related Side Effects and Adverse Reactions/prevention & control ; European Union ; Female ; Humans ; Pregnancy ; Risk
Language	English
Publishing date	2016
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.378
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Article ; Online: Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.

Tomasi, Paolo A / Egger, Gunter F / Pallidis, Chrissi / Saint-Raymond, Agnes

Paediatric drugs

2017 Volume 19, Issue 6, Page(s) 505–513

Abstract: The year 2017 marks the tenth anniversary of entry into force of the Paediatric Regulation in the European Union (EU). This law aimed to stimulate the development of paediatric medicines and provide more information on their use, as a response to the ... ...

Abstract	The year 2017 marks the tenth anniversary of entry into force of the Paediatric Regulation in the European Union (EU). This law aimed to stimulate the development of paediatric medicines and provide more information on their use, as a response to the lack of evidence and approval of medicines for children. The European Medicines Agency (EMA) has had a central role in the implementation of the Regulation. Pharmaceutical companies need to submit a paediatric investigation plan (PIP) to the EMA's Paediatric Committee (PDCO) for every new medicine, unless an exemption (waiver) is granted. The plans, which describe the development of drugs for children, must be agreed well in advance of the request for marketing authorization of the medicine. Deferrals of studies can be granted to allow approval in adults before the completion of paediatric studies. Between January 2007 and December 2016, a total of 273 new medicines and 43 additional pharmaceutical forms appropriate for use in children were authorized in the EU, and 950 PIPs were agreed by the EMA. In addition, 486 waivers of the development of a medicine in one or more medical conditions were agreed. The Paediatric Regulation has had a very positive impact on paediatric drug development, as exemplified by a comparison of two periods of 3 years before and after entry into force of the Regulation. We conclude that the Regulation has resulted in more medicines for children and more information on the pediatric use of medicines in the EU being available to clinicians.
Language	English
Publishing date	2017-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	1492748-2
ISSN	1179-2019 ; 1174-5878
ISSN (online)	1179-2019
ISSN	1174-5878
DOI	10.1007/s40272-017-0261-1
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