Benuvia’s Post

Why is industry relevant to making the UK more attractive for clinical trials? Read all about it in The Association of the British Pharmaceutical Industry (ABPI) latest report titled: The value of industry clinical trials to the UK. #industry #ABPI https://lnkd.in/epWqWh5v

Update in the British Pharmaceutical Industry On 23 September 2024, the Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) unveiled the updated “orange” 2024 Code of Practice and came into effect on October 1st. This new Code introduces significant changes to: - PMCPA Constitution and Procedure - Provision of Prescribing Information - Mandatory Requirements The updated Code aims to elevate the high standards expected of pharmaceutical companies and expedite the resolution of complaints. Key highlights include a new abridged complaints process and enhanced authority for the Appeal Board. The updated 2024 Code introduces a new requirement at Clause 5.2, mandating that all company personnel maintain a high standard of ethical conduct and comply with all relevant Code requirements. To support this, companies must now have clear policies and provide appropriate training to communicate corporate standards and expectations. However, it is important to note that Clause 5 clarifies that a breach can be found even where an employee is “acting contrary to the instructions which they have been given”. https://www.pmcpa.org.uk/ #PharmaceuticalIndustry #ABPI #PMCPA #CodeOfPractice #Healthcare #Compliance #PatientSafety

The UK medicines regulator has reminded pharmaceutical companies of new labeling requirements starting January 1, 2025. Post-Brexit, all medicines sold in the UK must feature a "UK Only" label or sticker, indicating they are not for the EU market. Read more: https://lnkd.in/dsCJeyrz #UKPharma #Brexit #MedicineLabeling #PharmaceuticalRegulation #UKOnly #MedicinesSafety #HealthcarePolicy

Gland Pharma Limited, a prominent player in the pharmaceutical industry specializing in generic injectables, has achieved a critical milestone with the United States Food and Drug Administration (USFDA) approval for its Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill).\ Read More :- https://lnkd.in/geG2AcxR #GlandPharma #PharmaceuticalIndustry #USFDA

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

In Spain, the Information Centre on Supply of Medicines (CISMED), established by the Spanish General Pharmaceutical Council (GPC) manages #information about #medicines not delivered to #pharmacies by wholesalers which is sent automatically by pharmacies to the regional pharmaceutical councils and then processed by the GPC, who then #reports the information to the National Competent Authority.   See more Best Practices from Pharmaceutical Group of the European Union (PGEU) members in addressing medicine shortages at https://lnkd.in/dgjKYNYG Consejo General de Colegios Farmacéuticos

We at AvKARE, LLC and R & S Northeast fully support HDA - Healthcare Distribution Alliance’s statement regarding the FDA's decision to grant an exemption for eligible trading partners from the DSCSA’s enhanced drug distribution security (EDDS) requirements. This action reflects a thoughtful response to stakeholder feedback and prioritizes patient safety and access to essential medications. As dedicated pharmaceutical partners, we recognize the importance of ensuring the integrity of the drug supply chain while also understanding the operational challenges faced by trading partners. We remain committed to working alongside HDA - Healthcare Distribution Alliance, our distributors, and public and private sector partners to foster collaboration, share critical information, and support the secure, efficient delivery of medicines to patients and providers. Our shared mission is clear: to ensure that healthcare institutions and providers can safely access the vital medications they need to care for their patients. We look forward to continuing these efforts in line with the #DSCSA’s goals, always with patient safety at the forefront. #DSCSA #HDA #healthydelivered #healthcare #pharmaceuticals #avkare #rsnortheast

The Pharmaceutical Care Management Association (PCMA) released the following statement on the inclusion of substantial, misguided policies targeting prescription drug benefits, in both Medicare and the commercial marketplace, in the text of a proposed government funding package. https://lnkd.in/eiv9E9xY

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 Commission is proposing amendments to the EMA Variations Guidelines. This will affect human medicines, Commission Regulation (EC) No 1234/2008, Regulation (EC) No 726/2004, and Directive 2001/83/EC. In collaboration with EMA and HMA, the Commission invites feedback from pharmaceutical industry representatives and other interested parties. These proposed changes focus on guidelines for the various categories of variations and their procedures. #EMAGuidelines.