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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 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 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 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 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 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 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 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 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 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 reports that the European Medicines Agency (EMA) is under pressure to exert tighter standards on biosimilars that are marketed in Europe as of 2015. Topics include the number of regulatory issues with biosimilars that need to be resolved by EMA, the argument of the opponents of EMA's position that biosimilars' labelling should focus on the quality characteristics, and the disagreements over labelling in the European Union.