Search

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 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 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 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 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 focuses on the concerns raised by European Generic Medicines Association (EGA) about potential fees to be charged by the European Medicines Agency (EMA) for pharmacovigilance activities in Europe.

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 offers world news briefs related to the pharmaceutical industry in Europe and in the U.S. A reminder was released by the European Medicines Agency (EMEA) on the Electronic Common Technical Document format. Merck & Co. Inc. defined its new organizational structure and top executives in effect of its merger with Schering-Plough Corp. Researchers encourage the U.S. Food and Drugs Administration (FDA) to require the producers to tell how new medicines equate with same interventions.

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.

The article focuses on efforts of the European Union (EU) in introducing initiatives for effective pharmaceuticals inspection procedures. It mentions that European Medicines Agency (EMA), an agency of EU, along with European Directorate for the Quality of Medicines & Healthcare (EDQM), a directorate of the council of Europe, monitors the quality of finished drugs. It also reports that EDQM runs a testing program for medicines approved under the EU's licensing procedure.

The article discusses the move of the European Union to strengthen its role in regulating biosimilars by developing basic regulations for determining their compatibility and safety. It notes the workshop on biosimilars organized by the European Medicines Agency (EMA), which focused on the revised guideline, principles, and quality issues of biosimilars. However, it also mentions the lack of knowledge on some aspects of biosimilars which needs more learning on how they should be regulated.

The article offers information on the improved efforts of European Commission (EC) and European Medicines Agency (EMA) on the implementation of quality-by-design (QbD) principles into the biotechnology industry's guidelines and regulations. It says that EC and EMA were alarmed due to the increasing number of medicine's quality defects. It adds that the biotechnology industry wants to enhance the use of International Conference on Harmonisation (ICH) guidelines that contain basic QbD principles.

This article discusses the collaboration of the European Medicines Agency (EMA) with the U.S. Food and Drug Administration (FDA) and its counterparts in Japan, India and Russia. It describes the impact of the collaboration on drug applications and reviews in Japan. The effects of EMA's relationships with the U.S., India and Russia are also explored.

The article discusses the existing standards for cleanroom operations under the U.S. Food and Drug Administration's (FDA) and European Medicines Agency's (EMA) guidelines. The author offers his views on the factors to be considered before validating a new cleanroom facility. He mentions that the expectations of FDA and EMA in regards to environmental monitoring do not consider the realities of aseptic processing. He adds that there is no assurance on the scientific reality of sterility tests.

The article offers news briefs related to various pharmaceutical companies which include European Medicines Agency's call for a feedback on the use of biosimilar medicines and influenza vaccines, AstraZeneca PLC's investment in an intravenous drugs manufacturing company to be established in China, and the U.S. Food and Drug Administration's decision to implement specific search criteria to its database.