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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 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 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 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 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 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 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 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 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 reports on the European Medicines Agency's (EMA) revised overarching guideline on principles of biosimilars approval and labelling to be implemented in April 2015. It mentions that the critics of the EMA's policy has been led by two trade bodies including the European Association of Bio-industries (EuropeBio) and the European Biopharmaceutical Enterprises (EBE). It highlights how the biosimilars' summary of product characteristics (SmPC) has been derived from reference product.

The article discusses the impact of delay in adaptation of European Union(EU) guidelines for good manufacturing practice (GMP) on the investment decisions of pharmaceutical industry. Topics include incorporation of key sections of the GMP guide including good distribution practice (GDP), comments of European Medicines Agency (EMA) on behalf of trade associations and professional association concerning guidelines, and enforcement of EMA for moving its headquarters from London to Amsterdam.

The article offers information on the new draft environmental risk assessment (ERA) guideline for pharmaceutical manufacturers which has been released by the European Medicines Agency, and outlines details on its objectives and compliance considerations.

The article discusses the possible introduction of emergency regulations to ensure continued access of medicines after the British withdrawal from the European Union (EU) in March 2019. Topics include the regulatory uncertainty and inactivity of the pharmaceutical industry due to Brexit, the suspension or reduction of operations of the European Medicines Agency as it moves to the Netherlands and the possible disruption in the movement of medicines and clinical trials in Great Britain and EU.

The article reports on the guidelines on integral drug-device combinations (DDCs) for pharmaceutical companies in Europe. Topics discussed include the Medical Devices Regulation (MDR) of the European Union, the process for the assessment of DDCs by the notified bodies (NBs), and guidelines on issues like pharmacovigilance and anticancer medicinal products.

The article discusses the shift toward continuous manufacturing among European pharmaceutical manufacturers. Topics discussed include increase in the use of automation and sensor-based on-line monitoring; technology providers in the region led by Siemens AG and statement of Parenteral Drug Association (PDA) on impact of national-level post-approval changes on its members. It adds role of European Union's European Medicines Agency (EMA) in promoting innovation.

The article discusses the impact of the Brexit on the British drug supply. Topics discussed include separation of drug companies from the networks of life science collaboration along with the European Medicines Agency (EMA), comments from Mogens Peter Carl on same and needs to start exploring accommodations with negotiating partners on cross-border trade.

The article discusses the move of the European Union (EU) to offer scientific advice to pharmaceutical companies on major efficacy, safety, and quality issues to encourage drug development. The pharmaceutical trade and professional associations mentions the need for more advice on production processes and chemistry, manufacturing, and controls (CMC) for the development. The launch of PRIority MEdicines (PRIME) scientific advisory scheme by the European Medicines Agency (EMA) is also tackled.

The article focuses on the application of health technology assessment (HTA) in European pharmaceutical sector. Topics include the effort of the European Federation of Pharmaceutical Industries and Associations (EFPIA) to apply a joint HTA with its own members, the action of the European Medicines Agency (EMA) to start intensive discussion between HTA bodies, and comments from European Commission's acting director general for health Ladislav Miko.

The article discusses the concept of medicines adaptive pathways to patients (MAPPS) in Europe. It highlights the medical approaches of the European Medicines Agency (EMA) of the European Union (EU) with an access to medicines scheme in several countries including France, Belgium and Spain. It also emphasizes the safe and timely access to medicines for patients (STAMP) EU expert group aimed to provide advice and assist patients.

The article focuses on issues related to labeling of biosimilars that are needed to be addressed by the European Medicines Agency (EMA). It mentions that the EMA's biosimilar labeling is based on 2012 guidelines which states that biosimilar's summary of product characteristics has to be derived from those of the reference product. It informs that the European Biopharmaceutical Enterprises and European Association of Bio-industries claim that biosimilar labeling is similar to generic medicines.