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The article focuses on EMA's promotion of real-world data (RWD) in non-interventional studies for generating real-world evidence (RWE), addressing methodological aspects, governance, and data quality, aligning closely with FDA guidance but highlighting differences in NIS definitions, aiming to enhance regulatory decision-making and scientific rigor while improving transparency and reliability of industry-generated RWD.

The article provides an answer to the question on whether splitting a commercialize batch of a new drug into sub batches for process validation and stability data requirement purposes is compliant with U.S. and European Union pharmaceutical industry regulations.

The article discusses the efforts put in by European Union (EU) in handling the problem of drug shortages. It is mentioned that the EU established a task force in December 2016 with European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) to offer solution for disruptions to drug supplies. The article also talks about effect of Brexit on the issue, serialization or barcode identification regulation, and challenges faced in keeping medicines available.

The article presents the new regulatory guidelines related to the U.S. Food and Drug Administration (FDA), International Conference of Harmonisation (ICH) Manufacturing, and European Medicines Agency (EMA) that was issued on June 2011 to May 2012 including size of beads in drug products, direct-to-consumer television advertisements, and DNA vaccines.

The article focuses on biosimilar guidelines by the European Medicines Agency (EMA). Details concerning the guidelines for various product classes of biosimilars such as low molecular weight heparins (LMWHs), erythropoietins, and monoclonal antibodies (MAbs) are provided. The difference between the EMA and the U.S. Food and Drug Administration (FDA) concerning guidelines for the development of biosimilars is also tackled.

The article discusses regulatory aspects transition from clinical to commercial supply chain in the pharmaceutical industry. It states that challenges faced in selection of drug substance regulatory starting materials (RSMs), and mentions the emphasis during pharmaceutical development on the portion downstream of the RSMs. It notes that the European Medicines Agency (EMA) published a reflection paper on the requirements for selection and justification of starting materials.

The article discusses the innovative approaches used by pharmaceutical companies to improve patient experience and patient outcomes in taking their medication. Guidance documents encouraging pharmaceutical companies to design products that promote patient compliance and reduce medication errors has been issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The article lists several manufacturing guidelines of the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) that issued in 2013 including the FDA Draft Guidances, the EMA Draft Papers and the FDA Final Guidances.

The article focuses on insights provided by Steffen Thirstrup, the chief medical officer at the European Medicines Agency, regarding regulatory challenges and successes in Europe's pharmaceutical landscape. Topics discussed include the impact of the COVID-19 pandemic on regulatory agility, challenges and collaborations in drug pricing and reimbursement, and efforts to enhance supply chain resilience and proximity to manufacturing infrastructure.

The article focuses on the new European Union (EU) guidance for drug developers regarding the conduct of paediatric investigation plans (PIPs) issued by the European Medicines Agency (EMA) on February 6, 2023. It informs that the guidance was issued to address shortfall in paediatric regulation and improve harmonization of pedantic regulations.

The article focuses on the emergence of advanced manufacturing technology in the biopharmaceutical industry, indicating a shift toward distributed manufacturing models. Topics discussed include the U.S. Food and Drug Administration's recognition of the need for flexible manufacturing, regulatory challenges, and the potential of point-of-care (POC) manufacturing to address issues such as drug shortages and pandemic preparedness.

The article reports on the new guidance on the manufacture of stem cells which was released by the European Medicines Agency (EMA) on February 4, 2011 in the U.S.

The article discusses nanomedicines in context of regulatory difficulties faced. It informs that nanomedicines have been authorized by the European licensing agencies for more than 30 years. It states that safety rules on nanosubstances in medicinal products in Europe are perplexing because nanotechnologies are applied to drug-delivery systems, carriers, and imaging agents. It states about reflection papers of the European Medicines Agency (EMA) on nanotechnologies.

The article focuses on the regulatory issue and concerns on data integrity in good manufacturing practice (GMP)-regulated laboratories. Topics discussed include the focus of inspection on electronic records and computerized systems, the non-compliance to European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), and the use of laboratory information management system (LIMS) for data management and documentation.

The article discusses need for improved transparency and reliability of information in the quality assessments of biosimilars in order to ensure its safety and efficacy. It mentions expansion of European biosimilars market as a result of increase in government-funded healthcare services order to reduce costs. It also discusses efforts of the European Medicines Agency to increase efficiency of analytical methods for the collection and assessment of quality data.

The article discusses the increasing pressure on pharmaceutical companies to meet sustainability goals and objectives set by national governments and regulatory authorities. It explores the evolution of regulatory requirements related to drug development, marketing authorization, and monitoring set by the European Medicines Agency (EMA) and national pharmaceutical regulators. It further discusses the changes to supply chain regulations in Germany.

The article discusses that the biosimilar landscape in Europe is set to continue expansion between 2021 and 2026, with key drivers for the growth including the loss of patent protection for several biologics in Europe. It mentions that the European Medicines Agency and the Heads of Medicines Agencies have provided comprehensive guidance for manufacturers, sponsors, and marketing authorization holders to clarify the requirements and guide product development.

The article focuses on the approach of pharmaceutical industry of Europe related to the issue of the regulation of control on combination products by a centralized pharmaceutical-type approval system. It informs that majority of the industry wants to retain a decentralized system. It also discusses the role of European Medicines Agency (EMA), public and animal health protection agency, related to the issue of the regulation of centralized system for pharmaceutical and medical devices.

The article offers the author's insights on biosimilar regulatory frameworks with emphasis on regulated biosimilar market and unregulated market in Europe. He notes that the European Medicines Agency (EMA) has refined its biosimilar guidelines to cover specific classes of biosimilar products, making the development of biosimilars more expensive and time-consuming. He stresses various significant factors that pharmaceutical companies need to consider when entering the biosimilars market.

The article reports on the agreement among heads of the European medicines agencies that all European Union (EU) members must have the infrastructure and processes to handle only electronic common technical documents(eCTD). It states that the reason behind that agreement was to support the decision-making processes for medicinal products within the EU. It notes that the European Medicines Agency (EMA) is committed to electronic submission by mandating the use of the eCTD format.

The article focuses on the struggles of the European regulators with globalisation and clinical trials. It says that the clinical trials expanded by the pharmaceutical industry have been viewed with concern in some quarters. It adds that the European Medicines Agency (EMA) has collected data on the numerical distribution of patients participating in pivotal trials included in the regulatory applications to priorities its international focus.

The article focuses on the debate of regulatory officials about the methods for producing water for injection (WFI) in Europe. It highlights the concerns of the European Medicines Agency (EMA) about reverse osmosis, including biofilm, bacterial endotoxins and microbial fouling. It notes the essence of the harmonization of requirements in giving pharmaceutical manufacturers a choice of technologies for producing WFI.

The article reports that unified plans are regulated in Europe to control medical devices and in-vitro diagnostic (IVD) tests. Topics discussed include low reliability of IVD tests due to inefficient evaluation of drugs and tests pairs by health technology assessment (HTA) bodies, the European Commission's two laws on IVD tests and medical devices, and the European Medicines Agency (EMA) to be consulted for suitability of devices and medicines.

The article offers information on the good manufacturing practices (GMPs) introduced by the European Union (EU) for managing the manufacturers of medicine excipients. It mentions that the EU is improving the quality issues that effects the human reproduction and development. The European Medicines Agency (EMA) manages the centralized pharmaceutical regulation in the EU.

The article focuses on the importance of project management in the pharmaceutical industry to promote drug approvals by government agencies following the decline in the number of drugs approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Topics include guides for the promotion of project management in drug development, the benefits offered by effective pharmaceutical projects, and the role played by a project management office (PMO) in a company. INSET: BEST REGULATORY PRACTICES FOR MANAGING PROJECTS WITH....

The article focuses on technological expectation of European Union computer systems performing good manufacturing practices (GMP) related functions is terms of data integrity of electronic records. It mentions that properly recorded and managed electronic information and metadata serve as basis for manufacturers to assure their products' identity, quality and safety. It also states the responsibility of European Medicines Agency to regulate medicinal products within the European Commission.

The article discusses the application of nanotechnology to drug delivery. It mentions that pharmaceutical firms such as N4 Pharma and Nanoform are pushing forward with their respective technology development using nanotechnology in drug delivery applications. It states that neither the Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) place specific barriers on a company using nanotechnology as part of its drug delivery modality.

The article concerns permanent solutions to Europe's medicines supply problems. It reports that patient and consumer organizations in Europe were complaining about supply problems before the COVID-19 pandemic intensified the challenges, and they are not considering the recent remedial strengthening of the European Medicines Agency which will be sufficient to fill the aperture. It also reports that the industry wants better information on product availability from the European Union (EU).

The article discusses the European Medicines Agency's guideline on setting health-based exposure limits. Topics discussed include risk identification in the manufacture of different medicinal products, reevaluating cleaning sampling and analytical test method detection and permitted daily exposure values as a basis for establishing appropriate limits. Other topics include targeting organ toxicity or adverse effects.

The article discusses the guidelines of the European Medicines Agency (EMA) for the establishment of health-based exposure limits, effective on June 1, 2015. Topics discussed include the aggressiveness of the EMA guide with the consideration of the number of existing products, the daily exposure (PDE) values permitted by the EMA guidelines, and the inclusion of spreadsheet in the adequate documentation.

The article explores the legislative framework of alcohol-induced dose dumping (ADD) for modified-release formulations. Topics discussed include revolutionalization in the delivery of active pharmaceutical ingredient APIs using modified-release (MR) systems, use of polymer matrix or by a polymer film coating for controlling drug release and need for harmonization of the U.S Food & Drug Administration FDA and European Medicines Agency EMA guidelines concerning ADD in-vitro testing conditions.

The article examines the need for comprehensive reviews and strategies for managing mission-critical information in the U.S and Europe. Topics discussed include the U.S Food and Drug Administration warning letters and European Medicines Agency statements of Good Manufacturing Practice non-compliance, aspects of data integrity such as validated state of a process or a computerized system and importance of employees awareness. Also mentioned is the importance of validated computer system.

The article discusses the importance of monoclonal antibodies in unlocking the biosimilars market to experience real growth. It states the 40% increase in the estimation biosimilars development, according to American global management consulting firm McKinsey & Co. It also mentions the approval of the European Medicines Agency (EMA) on the development of biosimilar as well as the education of physicians, pharmacists and patients.