Myonex’s Post

On Wednesday, the European Parliament’s ENVI committee adopted its position on amendments to the EU pharmaceutical directive and regulation. These revisions are aimed at bolstering innovation and competitiveness within the European pharmaceutical sector, while also ensuring equitable access to medications across the region.   The adopted position, though less extensive than the European Commission's original proposals, carries significant implications for pharmaceutical organisations operating in Europe. Anne Dhulesia and I outline the position adopted by the European Parliament, including details on changes to exclusivity periods for orphan and non-orphan drugs. #europeanpharma #orphandrugs #pharmaindustry #europeanpharma

Read up on the latest on the EU Pharmaceutical Directive from Sean Dyson and I as we outline the latest changes.

The German government's new Medical Research Act aims to streamline clinical trials and drug approvals, elevating Germany's position in pharmaceutical research. However, industry leaders have raised concerns. The Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller e.V. (VFA)) and the Initiative Studienstandort Deutschland (ISD) commend the initiative but stress the need for stronger measures. The German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie (BPI)) calls for amendments to ensure fair remuneration, regular evaluations, and faster contract negotiations. Learn more in our newest blog article. ➡️ https://lnkd.in/etRwEERN #MedicalResearch #Healthcare #Pharmaceuticals #Germany #Medizinforschungsgesetz #mfg #clinicaltrials

Dissecting the EU Pharmaceutical Landscape: Market Values Across Member States. Although the European pharmaceutical market is around EUR 255 Billion (2021 figures) it is not a unified market such as the US or China, but a fragmented market, whereby on a per country basis pricing and reimbursement needs to be obtained. This makes a broad market adoption for new products more difficult. Looking at the market value of the different EU countries, the 5 major markets consisting of the Germany, France, UK, Italy and Spain together make up around 60% of the total EU market. When partnering for the EU market finding a partner that covers the 5 major markets will therefore be a defining value driver for foreign companies. See below an overview of the pharmaceutical market value per EU country (source EFPIA - European Federation of Pharmaceutical Industries and Associations).

🇪🇺 European Commission Call for Evidence 🫵 The #EuCommission would like to hear your views on 💊 #Pharmaceuticals - changes to marketing authorisations (review of EU rules) ⌛️ feedback period 29 August 2023 - 26 September 2023 👀This initiative, announced in the 2020 pharmaceutical strategy for Europe, aims to review the current rules setting out the procedures for post-authorisation changes to a marketing authorisation for medicines for human use. The purpose is to make the lifecycle management of medicines more efficient. 🔗 https://lnkd.in/dsEHX2yZ #Deloitte #DeloitteLegalItaly #LifeSciences #Pharma Josephine Romano Andrea Pane

The SME office at The European Medicines Agency organised a virtual webinar on the revision of the pharmaceutical legislation. The aim of the webinar was to raise awareness of the proposed changes that will mostly impact small and medium-sized enterprises. Key findings can be found below and on the EMA website. - To discuss the key points raised in in the EU Pharmaceutical Reform Virtual Webinar, get in touch www.scendea.com/contact - #guidanceupdate #EMA #pharmaceuticallegislation #regulatoryaffairs

Have you been affected by the MHRA's capacity issues? This interesting article on the RAPS website discusses the call for more funding for the MHRA from The Association of the British Pharmaceutical Industry (ABPI). https://loom.ly/o5POzWM #RAPSorg #MHRAmedicines #ABPI_UK

Regulators from around the world are working together to ensure patients can have a continuous supply of life-saving medicines.    Learn more about this important work and read the summary report from a joint workshop by the International Coalition of Medicines Regulatory Authorities (#ICMRA) and the International Federation of Pharmaceutical Manufacturers and Traders (IFPMA).   The report outlines progress made and key learnings from ICMRA’s pilot programmes: https://lnkd.in/ebHv94v5  #GlobalCollaboration #PQKMS

Each year, EFPIA - European Federation of Pharmaceutical Industries and Associations publishes data comparing the availability and the average time it takes to make new medicines accessible to patients across 36 European countries. This article explains what the data shows and what it means for patients in the UK. https://lnkd.in/em4sYVDz

The European Medicines Agency is hosting an Awareness Session on the upcoming reform of the pharmaceutical legislation. This session is specifically target to small and medium-sized enterprises. Join us on 24 November at 10:00 am to learn more about the proposed changes! #pharmaceuticallegislation #regulatoryaffairs #SMEs #europeancommission #EMA https://lnkd.in/eNNP4z2n