The European Medicines Agency (EMA) has published additional information on biosimilar medicines, as part of their ongoing work to improve understanding of biosimilars across the EU. A biosimilar is a biological medicine that is highly similar in all essential aspects to a ‘reference’ biological medicine already authorised. The new material includes an animated video for patients […]
Improving understanding of biosimilars Read More »
Pharmaceutical spending accounts for approximately 20{ddf8d179d1bf712bb2a88ff2ad95ebdf63eaa5463c845d2f093b25848387ba96} of total health spending in OECD countries when taking into account medicines dispensed in both outpatient and inpatient settings of care. Recent developments in the pharmaceutical market and spending raise concerns for the future: Spending has become increasingly skewed toward high-cost “specialty medicines” which now account for between 30{ddf8d179d1bf712bb2a88ff2ad95ebdf63eaa5463c845d2f093b25848387ba96}
Pharmaceutical spending Read More »
There are important differences in the markets for medicines in countries in Asia and the Pacific in this study. These are mainly due to the political, financial and regulatory environments as well as characteristics of the pharmaceutical manufacturing industry. However, all countries face the test of transition brought about by demographic changes, shifting epidemiological trends
How Pharmaceutical Systems are organized in Asia and the Pacific Read More »
Senior officials from the European Commission (EC), together with the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, discuss strategic priorities for
EU/US collaboration on medicines and tobacco Read More »
Falsified medicines are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health. As falsified medicines become more sophisticated,
Falsified medicines Read More »
Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU: The European Medicines Agency and the European Commission have published additional guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union. Companies are reminded to plan in advance for the situation that the United Kingdom will leave the
Pharmaceutical companies and Brexit Read More »
Since 2001, EU rules have required the medicines we buy in the EU to contain a package leaflet which should provide us – the user, with clear information on the medicines we are taking – including the name of the product and the manufacturer, therapeutic indications, dosage, shelf life and adverse reactions. The Commission has
Medicine packaging Read More »
Pharmaceuticals in the environment represent a global pollution problem – over 631 different pharmaceutical agents (or their metabolites) have been detected in at least 71 countries covering all continents. Pharmaceutical residues have been detected in surface water, sewage effluents, groundwater, drinking water, manure, soil, and other environmental matrices. Antibiotics in the environment can promote the
Health care without harm Read More »
All medicinal products in the EU are subject to a strict testing and assessment of their quality, efficacy and safety before being authorised. Once placed on the market they continue to be monitored to ensure that any aspect which could impact the safety profile of a medicine is detected and assessed and that necessary measures
The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies. According to a new report from the OECD, ‘ New Health Technologies: Managing Access, Value and Sustainability’, pharmaceutical spending is increasingly skewed towards high-cost products. The launch prices of drugs
New approach needed to tackle rising drug prices Read More »
