Pharmaceuticals – Page 6
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JournalHM9: Patient engagement in the regulatory lifecycle of medicines
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session Leaders Fred Senatore, Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration ...
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JournalPS1:
Health technology assessment –
the new EU regulationRegulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Mariane Cossito, Head of Medicines Evaluation and Access Management Unit, Infarmed, Portugal. Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA. Speakers: ...
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JournalPS2: ATMP innovations and clinical trials with genetically modified organisms
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Jayne Hunt, Principal Regulatory Affairs Consultant, Ariello. Speakers: Patrick Ginty, Boyds Consultants. Isabel Borba Vieira, Nonclinical Assessor at Medicines Evaluation Department Scientific Evaluation Unit, ...
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JournalTOPRA Annual lecture
Dr Miguel Forte started his lecture by describing the fantastic cell and gene therapies (C>) opportunity for patients and other stakeholders in the pharmaceutical industry; he described a complex business with significant investment and value to patient in oncology and rare disease.
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JournalHM1: Update on EU new regulatory legislation − EMA, industry and others
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Leaders: Marta Marcelino, Head of Medicines Evaluation Department, PT CMDh Member, Infarmed, Portugal. Julie Taccoen, senior Director Regulatory Affairs, PTC Therapeutics, France. Speakers: Olga Solomon, Head ...
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JournalHM4: The evolving clinical trial landscape
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Carlos Alves - Vice President, Infarmed, Portugal Speakers: Olga Kholmanskikh, Clinical Assessor, Federal Agency for Medicines and Health Products (FAHMP), Belgium. Björn Eriksson, Director ...
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JournalOverview of importation
strategy from an
FDA perspective
– PLAIR vs FTZIn the current landscape, pharmaceuticals and biologics are manufactured at global current good manufacturing practice facilities for distribution in the US market. The importation of these products is a crucial process, as it ensures that patients can access these products in a timely fashion upon approval of applications to health ...
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JournalTransitioning from paper to electronic IFU for EU MDR 2017/745
The European Union Medical Device Regulation (EU MDR) Regulation (EU) 2017/745[1] amends current the EU Medical Device Directive (MDD) ‘93/42/EEC’ and the EU Active Implantable Medical Device (AIMD) ‘90/385/EEC’ directives. The regulation governs the manufacturing and supply of medical devices in the European Region and its territories. Several significant changes ...
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JournalAccess consortium: in the current submission transmission ecosystem
The Access Consortium is a medium-sized coalition of regulatory authorities that work together to promote greater collaboration and alignment of regulatory requirements. This union began in 2007 with the involvement of Australia, Canada, Singapore, and Switzerland, and was later in 2021 bolstered by the addition of the United Kingdom’s Medicines ...
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JournalControlled substances development – past, present, and future
Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...
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JournalA harmonised approach to clinical data standards
David Evans, President and CEO of Clinical Data Interchange Standards Consortium (CDISC), speaks to the journal’s November Issue Editor Leah Kleylein to discuss his role at the helm of the standards development organisation and the ways it is advancing global data standards in the clinical research realm.
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Industry newsMHRA seeks to cut approval time by 50% for ‘lowest-risk’ RCTs
The MHRA is set to introduce a new scheme which aims reduce the time taken by the agency to approve the lowest-risk clinical trials.
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Industry newsNICE approves use of Rimegepant in NHS to treat acute migraine
Rimegepant is the first, and only, NICE-recommended treatment for acute migraine and is soon to be made available on the NHS in the UK.
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Industry newsFDA committee finds OTC decongestants to be ‘ineffective’
An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.
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JournalQ&A:
Navigating the
pharmaceutical supply chainMatthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member
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JournalRegulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry
Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...
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JournalBiosimilars CMC development considerations from the sponsor perspective
Sponsors face significant challenges in the development of biosimilars, particularly in the chemistry, manufacturing, and controls (CMC) aspects. Key areas of biosimilar CMC development include establishing a reliable and consistent manufacturing process, controlling critical quality attributes, and developing analytical methods to assess product quality. Furthermore, sponsors must conduct extensive characterisation studies, encompassing physicochemical and functional assays, to demonstrate biosimilarity between the biosimilar and the reference medicinal product (RMP). This article provides insights from a sponsor’s perspective, highlighting the challenges and opportunities associated with the biosimilar CMC development process. By adhering to these recommendations, sponsors can navigate the complexities of biosimilar development and enhance the likelihood of successful outcomes.
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JournalWarning letters for direct-to-consumer advertising: a five-year retrospective analysis
Background: Direct-to-consumer pharmaceutical advertising (DTCPA) is a ‘grey area’ that the Food and Drugs Administration (FDA) in the United States (US) regulates through the Centre for Drug Evaluation and Research (CDER). One of the purposes of DTCPA is to educate and empower patients via popular media such as television, radio, ...
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JournalNavigating the global supply of starting materials for cell-based therapies
The use of biological starting materials in the development of allogeneic cell-based therapies poses several challenges, whether due to availability of appropriate donors, complicated global logistics, or lack of global regulatory harmonisation around technical testing requirements. Sponsors must pay attention to adventitious agent safety requirements, which vary from region to region, and can also be affected by emerging disease threats, as was the case with the recent COVID-19 pandemic. Dr Elena Meurer, principal consultant and director at Biopharma Excellence, and Dr Jennifer Sales, consultant at Biopharma Excellence, explore these complexities.
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Industry newsBurkina Faso gives R21 malaria vaccine approval in children
Burkina Faso’s regulatory agency – Agence Nationale de la Regulation Pharmaceutique – has approved the R21/Matrix-M malaria vaccine for children.