Regulatory Archives - Page 5 of 16

The Future of ATMPs under EU’s Updated SoHO Regulations

Blogs, Clinical Regulatory, Regulatory / development

The Advanced Therapy Medicinal Products (ATMPs) regulation was and covers gene therapy, somatic cell therapy, and tissue-engineered products. The ATMP’s requirements for the development, manufacturing, approval, and post-marketing surveillance for these products are regulated under regulation (EC) No. 1394/2007 and Directive 2001/83/EC in the European Union (EU). Stringent regulatory agencies, like the European Medicines Agency […]

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Navigating the New Requirements for Diversity in Clinical Trials

Blogs, Clinical Regulatory, Regulatory / development

In recent years, the emphasis on diversity in clinical trials has become more prominent, reflecting the need for studies on more diverse populations to gather more accurate clinical findings. The lack of diversity in participants can create an obstacle to understanding the safety and efficacy of new medicines, making it more difficult to understand the

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Key updates in ICH Q2 and Q14 guidelines for biologics

What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions

Blogs, Regulatory / development

The rapid advancement of biologics and the complexity of their development requires a meticulous approach to analytical procedures. With the revisions to the ICH Q2(R2) (Validation of Analytical Procedures) and the introduction of ICH Q14 (Analytical Procedure Development), biologics developers now have updated guidelines designed to address the unique challenges presented by these complex therapeutic

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Two advice pilots to improve clinical trials in Europe

Accelerating Drug Development with Europe’s New Clinical Trial Pilots

Blogs, Clinical Regulatory, Regulatory / development

The journey from discovering a promising compound to its approval as a safe, effective drug is challenging and costly, involving rigorous clinical trials to ensure public health and patient safety. The European Union responds to the need for speed and efficiency by transforming how clinical trials are conducted. The Accelerating Clinical Trials in the EU

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a scenario for biosimilar cell and gene therapies

What does the scenario of biosimilar cell and gene therapies look like?

Blogs, Regulatory / development

Cell and gene therapy (CGT) products are gradually paving the path to provide novel treatment options for patients that have complex conditions related to cancers, genetic disorders, and other chronic conditions. However, CGT products are also associated with barriers related to cost that could significantly affect or delay patient access to these life-changing therapies. Indeed,

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Safety Reporting Requirements in ctd to ctr transition

Complying with Safety Reporting Requirements in the EU’s CTD to CTR Transition

Blogs, Clinical Regulatory, Regulatory / development

Since 2004, clinical trials (CTs) in the European Union (EU) have been governed by the Clinical Trials Directive (CTD) 2001/20/EC. This directive aims to harmonize the administrative requirements governing CTs across EU Member States. Each Member State (MS) has its own set of procedures, requirements, and timelines for CT operations. However, there was a need

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FDA Launches REMS Public Dashboard to Enhance Transparency and Data Access

Blogs, Pharmacovigilance, Regulatory / development

The U.S. Food and Drug Administration has launched the REMS (Risk Evaluation and Mitigation Strategy) Public Dashboard to enhance access to data related to REMS programs using an interactive, secure, and web-based tool. Such a dashboard will help streamline user-friendly access for health care providers, research organizations, academia, industry professionals, and the general public to

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Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14

Blogs, Clinical Regulatory, Regulatory / development

Imagine a pharmaceutical company about to launch a new drug. Clinical trials have shown promising results, but the real test lies in how this drug will perform in the hands of thousands—or even millions—of patients in the real world. Will it be as effective? Will unexpected safety issues arise? The answers to these questions often

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Understanding Post-Approval Manufacturing Changes in Biosimilars and Interchangeable Products in USA

Blogs, Regulatory / development

After a biosimilar or interchangeable product gets regulatory approval by the USFDA, manufacturers often need to adjust their manufacturing processes. These changes after approval are essential for keeping product consistency, enhancing processes, or tackling operational issues. However, because biologics are complex, even small modifications can significantly affect the product’s safety, efficacy, and quality. As a

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Updates to the Declaration of Helsinki

Blogs, Medical Writing, Pharmacovigilance, Regulatory / development

The Declaration of Helsinki (DoH), the first international set of ethical guidelines for medical research involving human participants, marked its 60th anniversary this year. The members of the World Medical Association (WMA) General Assembly gathered to and unanimously approved significant revisions to the DoH. The DoH has always established that medical research involving human participants

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