• European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines

    The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to draw on lessons learnt from the presence of nitrosamines in a class of blood pressure medicines known as sartans.
  • Academia developing medicines for rare diseases to receive free EMA scientific advice

    News: 
    The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with a potential to benefit patients with rare diseases. Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines. However, feedback from academia showed that fees for protocol assistance (scientific advice for orphan medicines) represent a hurdle to engage with EMA. In light of these findings and the actions foreseen in the Agency's framework of collaboration with academia, the Regulatory Science Strategy to 2025 and the EMA SME action plan, EMA decided to include academia in the list of organisations PDF iconeligible for free protocol assistance as of 19 June 2020 . Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations. These entities should not be financed or managed by private for-profit organisations in the pharmaceutical sector or have concluded any agreement with pharmaceutical companies concerning their sponsorship or participation in a specific research project for which a fee exemption is sought. Fee incentives for orphan medicines are described in the ' PDF iconExplanatory note on general fees payable to the European Medicines Agency '.
  • METE PLASTİK HELPS FOR HEALTHCARE PROFESSIONALS BY PRODUCING FACE SHIELDS AGAINST COVID 19

    News: 

    We as METE PLASTIC INDUSTRY AND CO.INC. give most of the face shields that we produce to those healthcare professionals as a gift What we do is not enough for our healthcare professionals who present self sacrifice on these difficult days.

  • Coronavirus: An update from the Meech team

    News: 

    The situation with the Coronavirus/COVID-19 is, as I’m sure you’re aware, constantly evolving. Our senior management team are meeting regularly to review the guidance we receive and the advice we give. We have also updated our procedures to ensure we are able to honour our commitments to our team and our customers. Our intention at this time is to maintain an uninterrupted supply chain, this will include functioning production, order processing and technical departments, along with a customer service support team. This will allow is to meet customer’s demands with the same high standards we usually work to. We will be reviewing this regularly and can reassure you that we are taking action to minimise risks, where possible. This includes: Risk Assessment We have carried out a full risk assessment of our headquarters. This includes; · Prioritising the departments most at risk and looking for alternative ways of working where necessary. · Restricting face to face meetings and running conference/video calls where possible. · Putting in place measures that allow staff with children and at-risk family members to look after them if needed, without disrupting business. Travel restrictions We have cancelled all non-essential travel both in terms of face to face meetings and overseas trips. Production isolation Having identified the production facility as a key area, we have restricted the physical interaction people have with this part of the business. This includes restricting entry to only key production personnel and prohibiting entry for external visitors. Communication We are issuing internal memos highlighting any new procedures and changes we are asking people to make. We will also be sending regular updates to our wider distributor network. Cleaning procedure We have established a cleaning rota for all communal areas, this is in addition to the increase in cleaning from our professional cleaning company. Working from home protocol We have now introduced a working from home policy where those who can are working from home. We have ensured everyone has the appropriate hardware for them to work effectively from home and allow a safe continuation of business. We have made every effort to balance the welfare of our team with the needs of the business. Whilst we hope these measures will only be temporary, we are confident that the company, its employees and distributors are well placed to deal with any challenges we face. We would also like to reassure you that whilst there is a chance of delays to orders in the future, at present, orders are being fulfilled as normal.

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

    News: 

    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

    News: 

    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.
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