Jan de Rijk Logistics’ Post

🌍 Big News for Pharma Shipping at CHALLENGE HANDLING ( part of CHALLENGE-GROUP)! 🌍 Exciting times are ahead with the launch of CEIV Pharma 2.0, an initiative aimed at refining the CEIV Pharma program based on past observations and feedback. We're following these developments as one of the first entities to be CEIV Pharma certified in 2015. What CEIV Pharma 2.0 Brings: 🔹Enhanced Supply Chain Management: Aiming for excellence at every step of the pharmaceutical supply chain. 🔹Streamlined Certification Management: Focusing on comprehensive coverage for all stakeholders in the pharma supply from airlines to logistics providers. 🔹Refined Evaluation Process: Ensuring even safer and more secure pharma shipments through improved assessments. ✅ These improvements mark a significant step forward in pharmaceutical logistics, enhancing the current IATA CEIV Pharma program. As we watch the implementation phase of CEIV Pharma 2.0 unfold, we're proud to continue upholding the high standards set by our initial certification. 👏 Our commitment to excellence in pharmaceutical logistics remains unwavering as we serve our customers in the life sciences industry. International Air Transport Association (IATA) Pharma.Aero #ChallengeAccepted #CEIVPharma2 #PharmaLogistics #HighStandards #LifeSciencesLogistics

Menzies Aviation has been awarded the prestigious International Air Transport Association’s (IATA) CEIV Pharma accreditation, making it the first in the Middle East, Africa, and Asia (MEAA) region to achieve this certification. This follows improvements in their temperature-controlled pharmaceutical shipment capabilities in Kenya at their recently opened facility, which now becomes the seventh Menzies facility to receive this accreditation. The three-year accreditation is granted to companies that demonstrate the high standards set by the IATA’s Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma), including best practices in handling high-value, time-sensitive, and temperature-controlled pharmaceutical products. #kenya #internationalairtransportassociati #menziesaviation #tradearlnews

The International Air Transport Association (IATA) and the global collaborative platform Pharma.Aero have joined forces to strengthen IATA’s Certification for the Excellence in Pharmaceutical Handling (CEIV Pharma) programme, the certification for excellence in pharmaceutical-product handling. Trevor Caswell, Frederic Leger, #IATA #Pharma_Aero #CEIVPharmaprogramme #CEIVPharma #aircargo #aircraft #pharmaceuticalmanufacturers #newhub #cargoupdates #newspost #newsalert #newsupdate #topnews #latestnews #latestupdate #statmediagroup #explorepage #exploremore #instagramnews #newsdelivery #businessnews #cargomedia Read More: https://lnkd.in/d8v9jMU5

It was an honor for me to deliver an individual statement on behalf of the International Pharmaceutical Federation (FIP) (FIP) at the 77th World Health Assembly of the WHO, as an official delegate from the FIP Early Career Pharmaceutical Group. It focused on antimicrobial resistance (AMR) and antimicrobial stewardship (AMS), emphasizing pharmacists' role in promoting responsible and rational antimicrobial use. There is a policy statement from FIP on mitigating AMR through AMS for governments, policymakers, and pharmacists and their organisations. This statement describes the necessary actions and the commitment of FIP to mitigate AMR. #ThinkHealthThinkPharmacy #WHA77 #AntimicrobialResistance #AntimicrobialStewardship

Breaking the European Deadlock: Part 2 - Transferable Exclusivity Vouchers – Effective Pull Incentive or a Policy Distraction?      Our latest insight discusses the potential use of Transferable Exclusivity Vouchers (TEVs) in Europe and their likely impact on incentivising antibiotic development.      🔍 What are TEVs?  TEVs reward pharmaceutical companies developing essential drugs with an exclusivity voucher to extend the patent on another product. The voucher's value depends on market dynamics, exclusivity terms, and sales values of qualifying products.     The European Commission has proposed TEVs in the form of an additional year of regulatory data protection to developers, subject to conditions. Key aspects include a limit of 10 vouchers over 15 years, strict criteria for eligible antimicrobials, transparent R&D cost contributions, and EU supply obligations.     Arguments for and against TEVs include legislative advantages at the EU level and potential opposition from generic/biosimilar manufacturers. Critics raise concerns about cost, efficiency, and alternative incentive routes like revenue guarantees and R&D push incentives.     Are there any concerns?   🔻Challenges include potential high "rent" for TEV winners and variability in exclusivity values.  🔻Other issues include differentiation for antibiotic quality, potential excess TEV awards, and addressing unforeseen circumstances.     Read our full insight here: https://lnkd.in/dhjPuPu9

Maintaining the Nordic countries as “one of the most integrated regions for medicines in Europe”—that goal was reaffirmed at a meeting of the steering group of the Nordic Pharmaceutical Forum (NPF) in Stockholm on 7th May 2024. The meeting also considered additional activities and objectives for the group in the coming years, including its role in pan-European initiatives.   Tackling antimicrobial resistance is a priority for the NPF. Health ministers in the region announced plans for closer collaboration to safeguard supplies of antibiotics, including the possibility of joint procurement. Denmark, Norway and Iceland have developed a joint tendering procedure that features criteria related to the prevention of resistance.   At EU level, the NPF is a member of the European Commission’s recently formed Critical Medicines Alliance, which has been described as “the industrial arm of a strong European Health Union.” The Forum “will contribute actively with its experience on joint Nordic tendering procedures to the Commission, which is working to identify best practices in tendering procedures. When the Commission decides on best practices, their work will result in a number of recommendations for its member countries.” #Nordic #crossbordercollaboration #jointprocurement

Report 3 Three reports published by the European Federation of Pharmaceutical Industries and Associations show that disparities in the time it takes for European patients to access new medicines persist. Across the region, the average time to patient access is 531 days. Ranging from 126 days in Germany to 804 days in neighbouring Poland. The data shines a light on the delays and barriers to access that European patients face. Ensuring that medicines reach citizens regardless of where they live in Europe, is not only a shared goal but a shared responsibility. The current situation, where patients in one European country can wait more than 6 times as long as patients in a neighbouring country for the same medicines must be addressed. The Patient W.A.I.T. Indicator documents the time from EU marketing authorisation to the reimbursement of medicines in Member States, the portal allows us to look in greater detail at the timings of different steps in that process. The data shows that the majority (71%) of the time between EMA approval and reimbursement occur after a product has been filed for pricing and reimbursement (P&R). The remaining 29% happens prior to filing for P&R.

After a high-level delegation from the World Health Organization visited the Egyptian Drug Authority: A step towards international accreditation A high-level delegation from the World Health Organization (WHO) concluded its visit to the Egyptian Drug Authority (EDA), which lasted for three days. During the visit, the delegation reviewed the significant efforts made by the EDA to enhance Egypt's drug regulatory system and secure WHO accreditation in the pharmaceutical field. Dr. Ali El-Ghamrawy emphasized during the closing session that the EDA is keen on obtaining this accreditation, following its prior success in achieving the third maturity level in the field of vaccines. These efforts are part of Egypt’s Vision 2030 and the directives of the country's leadership to localize pharmaceutical manufacturing in Egypt, while strengthening confidence in the safety, quality, and efficacy of Egyptian medicines both locally and internationally. The WHO delegation praised the progress made by the EDA, noting that these developments will play a key role in obtaining international accreditation. The delegation also expressed appreciation for the rapid improvements in Egypt's regulatory system to align with global regulatory standards. This visit represents an important step in boosting the reputation of Egyptian medicines and opening new opportunities for investment and export to global markets. #WHO #EgyptianDrugAuthority #PharmaceuticalSectorDevelopment #InternationalAccreditations #Medicines #Egypt2030 #PharmaceuticalIndustry #Investment #Export

#Regulatory: a landscape of international efforts in working together and simplifization for manufactuers through onsite and virtual inspection all together in one visit. Pilot GMP Single Inspection Program Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice (GMP) inspections of third country manufacturers. Health Canada | Santé Canada the Therapeutic Goods Administration (TGA)and the Medicines and Healthcare products Regulatory Agency (MHRA), all members of the PIC/S - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) ,  @International Coalition of Medicines Regulatory Authorities (ICMRA), and Access Consortium, have begun piloting a Good Manufacturing Practice (GMP) Single Inspection Program (SIP).  This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has agreed to extend the scope of an inspection to cover products of interest to one another, where possible, reducing the need for multiple inspections of the same site.  This builds on the success of our existing collaborative GMP arrangements and will allow for more efficient inspection reliance processes, reduced regulatory burden on industry and enhanced collaboration in our regulatory oversight of common global supply chains. https://lnkd.in/eaXfpDDf https://lnkd.in/eBY_Bd8U

Today the European Commission’s DG HERA (EU in Emergencies) launched the Critical Medicines Alliance (CMA). This is the “industrial policy” pillar of the EU strategy to tackle medicines shortages, alongside regulatory measures advanced via the revision of the EU pharmaceutical legislation. The CMA gathers 250+ stakeholders from public and private sector to jointly develop medium-term solutions. By the end of 2024, the Alliance will approve a Strategic Action Plan which at the moment focuses on 1) strengthening EU manufacturing capacity; and 2) Diversifying supply chains. The CMA follows the publication of the Union List of Critical Medicines by the EMA last year, with 216 medicines for now. As a member of the Alliance, Pfizer welcomes the opportunity to continue partnering with governments, EU institutions and relevant stakeholders to prevent and manage medicines shortages. We notably need to ensure coherence, proportionality and risk-based approach of any policy measures. Charles Faid EFPIA - European Federation of Pharmaceutical Industries and Associations Nathalie Moll