Despite the fact that the online channel has become an important point of reference for many people to purchase non-prescription drugs, consumers are only able to correctly classify half (53%) of online advertisements related to medicines as licit or illicit. This is the finding of the Project Capsule, conducted by the Transcrime Research Centre of Università Cattolica del Sacro Cuore of Milan with the support of the Office of Product Quality and Countering Pharmaceutical Crime of the Italian Medicines Agency (AIFA) and with the contribution of the Center for Anti-Counterfeiting and Product ..read more

The amendments to the International Health Regulations (IHR) were approved on 1 June 2024 during the World Health Assembly held in Geneva. The approval is the result of two years of intense negotiations. More than 190 countries were involved, among which also all EU Member States. The new text of the IHR aims to improve the management of public health emergencies of international concern and to better protect all citizens from serious cross-border health threats.  This is also a priority of the EU’s Global Health Strategy.  The legally-binding international rules were first agreed ..read more

The European Medicines Regulatory Network (EMRN) is the first international regulator recognised as a ‘single entity’ and designated as a ”Regional Regulatory System”. The EMRN was designated in May 2024 as WHO Listed Authority (WLA) by the World Health Organization (WHO). The designation covers each individual regulatory authority of the EMRN, as well as the EMRN overall. The network is composed of the the European Commission, EMA and the 30 national authorities of the European Economic Area Member States. The designation as WHO Listed Authority is a recognition of its advanced level of per ..read more

In 2023, EMA recommended the authorisation of 77 medicines for human use, including 39 with a new active substance, according to EMA’s annual report 2023. Among new treatments are also two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV). EMA also recommended for approval the first advanced therapy medicinal product based on the gene-editing technology CRISPR/Cas9 to treat beta thalassemia and severe sickle cell disease. The Agency also adopted two positive opinions for medicines for use in countries outside the EU. EMA’s three major str ..read more

Quality Culture has evolved into a critical component for biopharma and medical device companies since it was initially established in the early 2000s, when both regulatory agencies and industry were focused on increasing quality throughout the entire life cycle of product development. It has become clear that, whatever an employee’s position is – from technician to C suite executive – every department of the company should be built around quality so that the end goal is to ultimately provide the end-user – the patient – a quality drug or medical product. Over the past 10-20 years, companies ..read more

A recent report from the Access to Medicine Foundation focuses on five late-stage projects targeting some of the most severe drug-resistant pathogens, with the goal to favour access to newly-developed drugs by single patients who needs them. Late-stage R&D projects across the pipelines of GSK, F2G, Innoviva and Venatorx were monitored (gepotidacin, olorofim, zoliflodacin and cefepime-taniborbactam, respectively) as well as Pfizer’s recently approved aztreonam-avibactam (Emblaveo®). Four of the five companies analysed by the report (GSK, Pfizer, Innoviva and Venatorx) are initiating or co ..read more

In an area covering almost 1,400 sqm, the Pharmaceutical Divisions of IMA Group and its specialists are glad to introduce IMA Pharma, the All-In-One supplier specialized in the design and manufacture of innovative machines and complete lines for the processing and packaging of pharmaceutical and nutraceutical products, medical devices assembling, as well as projects concerning digitalisation, sustainability, and customer service solutions. Meeting the Divisions at the show IMA Active is the ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and bandin ..read more

EFPIA, representing the research-based pharmaceutical industry at the European level, released a white paper to support the principles of the EU Commission’s Circular Economy Action Plan. Implementation of a circular economy is fundamental to help limit global warming, an objective that is welcomed by the pharmaceutical industry. EFPIA wishes to work collaboratively with the EU in shaping the legislative framework and within its organizations to mitigate our impacts. The white paper addresses the changes throughout value chains needed to transition to a more circular economy, from product de ..read more

A coalition of several European organizations (EFPIA, Medtech Europe, Eurochambres, Digital Europe, Business Europe) released a new joint statement in view of the preparation of the Council position of the Commission’s proposal for a regulation on EU compulsory licensing for crisis management. Among amendments by the European Parliament positively judged by the associations are the greater involvement of the rights-holder, a requirement for attempted voluntary licensing, and a reasoned approach to remuneration. Nevertheless, according to the statement some problematic provisions  would ..read more

The annual meeting organised by EuropaBio, the European association representing the biotech sector, focused on discussions on the best ways to defragment and accelerate biomanufacturing in the EU, Biomanufacturing policies from other global regions were also addresses. Different policy files are underway at EU level, with an impact on relevant products or processes including biopharmaceuticals, new genomic techniques, detergents, alternative proteins and cell-cultivation . This Summit report summarises the Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis for biomanufact ..read more