• European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines

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    The collaboration between EMA and FDA formally started in 2003 and the two agencies have now almost daily interactions, most of them structured around working groups called 'clusters', some of which include contacts with other international regulators, with the aim to better align, and advance scientific and regulatory excellence worldwide. In the context of the COVID-19 pandemic, the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Given the medical emergency presented by COVID-19 and the importance of international cooperation to tackle this global crisis, the topic was high on the agenda of the bilateral meeting. Topics discussed included: Sharing of experience and common challenges in facilitating the development, review and availability of COVID-19 vaccines. Discussion about opportunities for cooperation on individualised/bespoke therapies for ultrarare diseases (e.g. gene therapies (advanced therapies/ATMPs); oligonucleotides) to jointly address their scientific and regulatory challenges. Real world evidence use to support regulatory decisions: through ICMRA, EMA and FDA have agreed to collaborate on observational research in COVID-19 as a model, specifically on vaccines surveillance, building international cohorts, and the use of medicines in pregnant women with COVID-19. Discussions focused on data provenance, quality and structure, on methods for generating evidence and opportunities to strengthen collaboration leveraging data from diverse digital sources to inform regulatory decisions. The partners agreed to collaborate on the development of a roadmap for international collaboration on real world evidence. Mutual recognition agreement (MRA) of good manufacturing practice (GMP) inspections: following the milestone reached in July 2019 with the full implementation of the MRA for certain human medicines, the partners discussed the next milestones. These include the expansion of the current MRA to veterinary medicines and the consideration to include vaccines and plasma-derived products by July 2022. Orphan and paediatric medicines: information sharing on initiatives on both sides of the Atlantic and discussion on possible cooperation in the area of data analysis for the characterisation of rare diseases. Notes The collaboration between EMA and the US FDA is outlined in the publication “Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?”

  • International regulators stress value of safe and effective vaccines

    EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). International regulators from around the world have come together and jointly developed these statements for healthcare professionals and the general public to give assurance that the regulatory processes for the authorisation and safety monitoring of vaccines are robust, independent and focus firmly on public health.
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020

    CVMP adopts a draft strategy on antimicrobials 2021-2025 CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a grouped type II variation application for Bluevac BTV8 to add the strains BTV1 and BTV4 into the vaccine. The Committee adopted by consensus a positive opinion for a type IB variation application for Stronghold Plus and Felisecto Plus (selamectin/sarolaner) to correct the translations of product information.
  • SURGE IN COUNTERFEIT GOODS DURING CORONAVIRUS OUTBREAK SPARKS HIKE IN DEMAND FOR AUTHENTICATION PROTECTION

    Speciality security printer Eltronis has reported a 20 per cent increase in enquiries for its brand protection and track and trace solutions since the outbreak of Coronavirus. The majority of these new enquiries have come from the pharmaceutical sector, reflecting the rise in public demand for immunity and health protection against the virus. Eltronis, which recently opened its European head office in the UK in Oxfordshire, delivers security and authentication solutions to leading global brands in the pharmaceutical, automotive, security, brand protection and industrial sectors.
  • Laser marking on biodegradable capsules

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    One of these innovative applications is biodegradable single-dose capsules. Manufactured with a plastic substance, it allows different products to be encapsulated by vacuum to maintain all their characteristics while offering a better experience to the end-user. Marking these types of capsules is done with CO2 laser marking system (with a 10.6 wavelength μm) that leaves a high contrast whitish mark without damaging the package and no risk of altering the characteristics of the product or breaking it. The fact that each capsule can be personalized with different complex information (such as logos, nutritional information, etc.) implies a high cadence of laser marking so a UHS (Ultra High Speed) head is used which allows working at extreme marking speeds without losing definition in the end result. Technical Information Laser: SPA CB 30 UHS Lens: 100 x 100 mm Market: Food Application type: Marking Product: Single-dose capsules Material: Biodegradable plastic Marking type: Dynamic Marking time: 200 m./min.

  • Abrasion-Resistant and Award-Winning: TEVA Relies on Schreiner MediPharm for Novel Adrenaline Injector Label

    Patients suffering from life-threatening allergies always carry a life-saving companion with them: an adrenaline autoinjector in order to immediately inject themselves in the event of an anaphylactic shock and to thus counter an allergic reaction. For the emergency drug epinephrine from TEVA, Schreiner MediPharm developed an Autoinjector-Label with special protection against abrasion. Thus, the vital user and product information remains perfectly legible over an extended period of time. The label won an award in the 2019 TLMI Competition.
  • Luminer Introduces Dedicated Inspection Suite at NJ Labels Manufacturing Facility

    Company inaugurates segregated 7,000-sq-ft space with a new back-number system and its third 100% inspection platform. Lakewood, NJ – Luminer, a labeling solutions provider specializing in extended content labels (ECLs) for pharmaceutical ethical and OTC packaging, clinical trials and various other narrow web applications for the cosmetics, F&B and chemicals sectors, has streamlined its precision product inspection capabilities by introducing a dedicated 7,000-square-foot inspection suite at its primary manufacturing facility in Lakewood, NJ. The quality
  • Honeywell: Aclar Edge Polymer Bottles and Vials

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    Honeywell announced Aclar Edge, a pharmaceutical packaging system for oral liquids for human health and sterile injectables for animal health applications. Designed with Honeywell’s proprietary multi-layer extrusion blow molding technology, Aclar Edge bottles and vials preserve shelf-life and efficacy for a wide variety of challenging liquid dosage forms while improving user safety during the handling and administration. Aclar Edge bottles and vials provide a moisture barrier performance that is comparable with glass and an enhanced oxygen barrier compared to other polymeric containers. In addition, Aclar Edge offers impact resistance and up to 75% weight reduction versus glass. Aclar Edge offers significant operational advantages by eliminating glass cracking and breakage, minimizing drug particulate contamination and reducing transportation cost. Unlike many plastic bottles used for liquids, AclarEdge reduces the risk of leachables from the container closure systems. Aclar Edge bottles and vials range in sizes from 100 ml to 500 ml and can be configured in threaded or crimped finish; commercial production will start in Q4 2020 for non-sterilized or gamma-sterilized formats. Pre-production samples of Aclar Edge are available now for customer evaluation.

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2020

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    Glossary: Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management. Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under Periodic safety update reports: questions and answers. Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk-management plans. Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS). Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures.

  • Highlights of Management Board: June 2020 meeting

    At its virtual meeting on 11 June, the Management Board was updated on how EMA is prioritising the response to the COVID-19 pandemic and what measures the Agency has put in place to tackle the crisis. The Agency and the European medicines regulatory network are currently operating under a network COVID-19 business continuity plan to ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of medicines continue to be carried out during the pandemic and do not incur any possible delays.
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