🔍 FDA guidance on postapproval manufacturing changes for biosimilar and interchangeable biosimilar products 📝 The FDA has issued draft guidance for manufacturers of biosimilar and interchangeable biosimilar products regarding postapproval manufacturing changes. This guidance provides recommendations for holders of approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new animal drug applications (ANADAs), as well as holders of drug master files (DMFs) and veterinary master files (VMFs). If you’re involved in drug substance manufacturing, this information is crucial during the postapproval period. #FDA #biosimilars #manufacturingchanges #pharmaceuticals 👩⚕️🔬
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CASE STUDY: Fulfilling Stability Data Requirements for ANADA Filings It is crucial to meet stability data requirements to ensure pharma products maintain their safety, efficacy, and quality throughout their shelf life. This is equally important for pharmaceutical products intended for animal use and is a requirement for abbreviated new animal drug applications (ANADAs) with the US FDA. This compliance is crucial for gaining approval to enter the US market and ensuring the health of animals. Read more about how DDReg provided hand-held support to its customers who wanted to bring their generic animal product to the US market. By conducting in-depth regulatory assessment to identify gaps, communication with the US FDA for scientific advice, and compiling the package to prepare a compliant dossier for submission https://lnkd.in/gYMENsn8 Meet us at DIA Global to know more about regulatory services for product registration with the US FDA: https://lnkd.in/grrwWGU6 #DIAGlobal #DIA2024 #pharmaceutical #regulatoryservices #product #USFDA #generic #ANADA
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We speak the same language and use the #3Baskets idea for a feasible roadmap to phase out animal testing - not only in Europe. Kirsty Reid, this morning after my opening words together with Jan Lund Ottesen, you asked me if I am feeling proud. I replied honestly yes. We all should be! Including controversial discussions, we work together for the same goal: safe and efficient medicine, preferably without animal testing. Kirsty Reid provided what Pharma industry achieved under the roof of #EFPIA. Jean-Pierre Valentin showed #ICH replacements for Basket 1 tests. Ganesh Balasubramanian presented Gilead Sciences animal-free IND for an oncology drug that’s now in Phase I. Christian Desaintes presented #ERA initiatives to move the needle. Sonja Beken showed how #EMA leverages the 3Basket approach with other agencies to overcome the biggest hurdle of replacing animal testing rather than displacing it from Europe: global acceptance - everywhere. Katrin Schutte, Elisabet Berggren and Denis Mottet thank you so much for the #EuropeanCommission perspective. It's great to see how you have taken the global industry view based 3 baskets and adapted it to inform the European way forward with the EC version of the 3 baskets. Frederic Pipp and Thomas Bertelsen your turn: the outcome of #EFPIA companies‘ 3 basket sorting. What a lift! Thank you so much. Laura Viviani thank you for sharing #HSI view on implementation. Dr. Tina F. your recommendations for Pharma-specific actions from #petascienceconsortium. Barney Reed you truly rounded it then altogether. "Yes, we can do, unless…!“ #RSPCA Nicolas Dudoignon and Sofia Östman led an effective workshop and panel discussion. Susanna Louhimies challenged how Europe can more forcefully influence globally. Although the EU has long replaced rabbit pyrogen tests, also companies headquartered here, need to carry it out to market products in certain countries. That the European pharmacopeia erased the test will speed up replacement globally rather than resulting in displacement from the EU only. Breakout sessions concluded: The 3-basket allocation is an important exercise. A careful mapping is crucial. In that context additional baskets were discussed, such as for obsolete tests. Regulators, not part of the current authority 3Rs initiative are to be picked up. Sorting requires continuous SME involvement. Agencies ask to share non-animal data. A plattform for sharing, e.g. owned by regulators, was appreciated by all. Basket 2 could be used to direct IMI initiatives and funding. Bold idea: Incentive to submit additional non animal data by prolongation of patent expiration time? Consortia could be the way forward. Katy Taylor summarized the key points at the end. The new level of transparency will allow success. I encourage to add what I missed and again, thank all for your engagement. #EPAA #EARA #3RWP #EDQM #eurogroupforanimals #animalhealtheurope #jrc #nc3rs #altertox #eceae #vaccineseurope
EFPIA is committed to a science-based phase-in of methods to reduce, refine and replace the use of animals. As part of our efforts, EFPIA has taken forward the #3 #Basket approach to support the European Commission in the creation of their #roadmap on the #phase #out of #animals in chemical safety #testing, to reduce reliance on animal testing in the pharmaceutical industry. Today, we are pleased to bring together stakeholders, the European Medicines Agency and the Commission for an open discussion. #MoreThanMedicine #WeWontRest
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EFPIA is committed to a science-based phase-in of methods to reduce, refine and replace the use of animals. As part of our efforts, EFPIA has taken forward the #3 #Basket approach to support the European Commission in the creation of their #roadmap on the #phase #out of #animals in chemical safety #testing, to reduce reliance on animal testing in the pharmaceutical industry. Today, we are pleased to bring together stakeholders, the European Medicines Agency and the Commission for an open discussion. #MoreThanMedicine #WeWontRest
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🌍 The #3Rs ➡️ From concept to full program DCL solutions can help you to tailor your own 3Rs program to foster your organization commitments. Do not hesitate to contact me. Many companies have developped their own ways to accelerate the implementation of 3Rs. What is yours? Where to start? How to value internal actions ? How to engage all actors in the company? Are you performing well? What are your indicators? In addition to the science et #ethics, it contributes to the #CSR reporting #lifescience #animalresearch #researchanimal #replacement
EFPIA is committed to a science-based phase-in of methods to reduce, refine and replace the use of animals. As part of our efforts, EFPIA has taken forward the #3 #Basket approach to support the European Commission in the creation of their #roadmap on the #phase #out of #animals in chemical safety #testing, to reduce reliance on animal testing in the pharmaceutical industry. Today, we are pleased to bring together stakeholders, the European Medicines Agency and the Commission for an open discussion. #MoreThanMedicine #WeWontRest
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The influence of CAS 41232-97-7 BMK Ethyl Glycidate extends across a multitude of industries: Pharmaceuticals: As a foundational ingredient in pharmaceutical synthesis, this compound contributes to the creation of a vast array of medications and formulations. Agrochemicals: Unleash the potential of agrochemical solutions fortified by the properties of BMK Ethyl Glycidate, elevating crop yield and agricultural outcomes. Veterinary Drugs: With its multifaceted attributes, BMK Ethyl Glycidate plays a pivotal role in the development of effective veterinary medicines. #OrganicChemistry #ChemicalIndustry #ChemicalSynthesis #ChemicalCompounds #ChemicalManufacturing
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Suggested reading on guideline that provides recommendations on how the risk management may be conducted for elemental impurities for veterinary medicinal products (VMPs) authorised or to be authorised in the EU, in order to comply with the requirement of the European Pharmacopeia (Ph.Eur.) General Monograph 2619 for Pharmaceutical Preparations. This guideline also provides information on the documentation expected to be included in the dossier in order to address this requirement. 📚 Read more here: https://buff.ly/41neBf7 #EBVS #VeterinaryMedicine #PharmaQuality #RiskManagement #EUvetspecialists
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Interesting topic at EUFEPS in Hungary - key learning for developers of veterinary medicines.
Argenta prepares to participate in the XVII Hungarian Pharmaceutical Congress and EUFEPS Annual Meeting next week! Dr. Klaus Hellmann, Chief Veterinary Officer at Argenta, will be speaking on: "The challenges registering human medicinal products for animal use: general aspects, orphan drugs, limited markets". We invite you to join us on 24 May in Debrecen, Hungary, for his presentation. Our Argenta team members will be available to chat with you, whether you have questions, ideas, or specific needs regarding your projects. We're here to collaborate and we encourage you to connect with us. #CRO #CDMO #AnimalHealth
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#Valnemulin is a semisynthetic pleuromutilin antibiotic derivative, is greatly active against Mycoplasma,especially those responsible for bovine respiratory infections. Stay with us:http://hanpets.com/ #pharma #veterinary #pharmaceutical #rawmaterial #apis #intermediates
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The India veterinary medicine market size has been estimated at USD 1.80 billion in 2023 and is projected to grow at a CAGR of 10.3% from 2024 to 2030. The veterinary drug approvals in India are governed by CDSCO FDA India MoHFW [Central Drugs Standard Control Organization] and @DAHD [Department of Animal Husbandry and Dairying]. The stratospheric industry growth is expected to increase the flow of drug approval applications to CDSCO and DAHD. Are CDSCO and DAHD ready to cater increase in number of applications? Yes! I am happy to share that this Initiative by CDSCO to digitize Drug Application submissions has been live since 16th August 2024. It is critical to note that online applications have now become mandatory for all veterinary drugs & biologicals. I believe this would increase efficiency and transparency of application review, which can lead to faster go-to-market time for these new drugs. Unfortunately till 2023, there were no formal guidelines for conducting clinical trials/field trials by either of these two bodies, but we are happy to see this changing as DAHD has officially release its formal guideline charter on 7th September 2023 which will enable manufacturers/applicants to follow the latest guidelines and expedite their drug approvals. CDSCO has also made it mandatory for applicants to obtain permission for clinical trials/field trials before initiation of any trials in India. The final guidelines of the above can be downloaded from: https://lnkd.in/gwKa3svJ. We at CliniExperts are here to advise you and facilitate the entire process for your veterinary drug/ biologicals/vaccines applications in India.
The Central Drugs Standard Control Organization (CDSCO) has made it mandatory to submit applications online to obtain New Drug permissions for vaccines, bulk drugs (API) in Form-45A/46A, and finished formulations in Form-45/46. Additionally, online submissions will be required for Field Trial Permissions related to veterinary purposes. Offline submissions will no longer be accepted starting from August 16, 2024. Visit Site:- https://lnkd.in/ghrfPkbn #CDSCO #NewDrugPermission #API #Form45A #Form46A #DrugApproval #August2024
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Learn more about the FDA Animal Rule and impact on drug development in this insightful blog: https://lnkd.in/gZcvDEAG #FDA #animalrule #regulatorysciences #drugdevelopment #ndapartners #propharma
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