In the rapidly evolving pharmaceutical landscape of the world, it is regulatory standards that ensure safe and effective drugs are delivered to patients. In Latin America, Brazil’s ANVISA has slowly been emerging as among the leading authorities of the region to help develop a more robust and globally harmonized framework. It stood out especially with […]
Unlocking New Potential with the AREE Update in Latin America Read More »
The landscape of pharmaceutical regulatory affairs is developing at a rapid pace in multiple verticals to help enhance efficiency while ensuring strict compliance. This can be relatively daunting highlighting the need for robust systems and tools that can be integrated in daily work to improve operational efficiency. Electronic Document and Records Management Systems (EDRMS) solutions
Boost Efficiency and Compliance with EDRMS Solutions Read More »
In the rapidly evolving landscape of pharmaceutical safety, integrating Artificial Intelligence (AI) into literature monitoring in pharmacovigilance processes has become necessary. It involves ongoing monitoring and assessment of adverse drug reactions (ADRs), and other potential risks associated with medicinal products. A critical aspect of PV is literature monitoring, which entails reviewing scientific literature, case reports, and
Harnessing AI for Enhanced Literature Monitoring in Pharmacovigilance Read More »
The United States Food and Drug Administration (USFDA) introduced the electronic Submission Template and Resource (eSTAR) program as part of its efforts to modernize and streamline medical device submission. This initiative aims to streamline the 510(k)-submission pathway, which is essential for manufacturers seeking to bring new medical devices. As of Oct 1, 2023, the use
A Guide to Using FDA’s eSTAR for Medical Device Submissions Read More »
The European Union’s Medical Device Regulation (MDR) 2017/745 has significantly transformed the regulatory affairs landscape for medical device manufacturers by establishing strict requirements to ensure the safety and efficacy of devices before they reach the European market. These regulations demand detailed technical documentation, comprehensive clinical evaluations, and proactive post-market surveillance, creating substantial resource and time
How LLMs like ChatGPT Can Simplify Regulatory Affairs for New Medical Devices Read More »
Medical Devices are an important part of the healthcare delivery system used in the diagnosis, monitoring, and management of diseases. Recent scientific innovations and technological solutions have expanded the use of medical devices globally. Medical devices can include items such as apparatus, instruments, appliances, substances, in-vitro reagents, software, etc. and other related objects used for
Identifying Barriers in Reporting Medical Device Adverse Effects Read More »
The European Union (EU) has long been recognized as a global leader in pharmaceutical legislation. In light of evolving healthcare needs, patient care, and technological advancements, the EU amended 2 of their legislative frameworks on April 10th, 2024, named Directive on medicinal products for human use and the Regulation on authorisation and supervision of medicinal products for
Adapting to Changes in EU Pharmaceutical Laws Read More »
In recent years, the pharmaceutical industry has been under increasing pressure to improve transparency, particularly when it comes to sharing clinical trial data. As the demand for open access to clinical research grows, regulatory bodies are stepping up to ensure that public health decisions are made based on comprehensive, accessible information. The European Medicines Agency
What EMA Policy 0070 Means for Global Clinical Trials and Regulatory Practices Read More »
As the healthcare and pharmaceutical industries increasingly turn to data-driven solutions, the integration of real-world data (RWD) into regulatory decision-making has emerged as a key focus for enhancing pharmaceutical practices. Utilizing data from Electronic Health Records (EHRs) and medical claims can provide valuable insights into patient care and treatment outcomes. This strategy has the potential
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
The Future of ATMPs under EU’s Updated SoHO Regulations Read More »
