Pharmaceuticals – Page 6
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JournalUS FDA CDER and CBER guidance of interest
The US Food and Drug Administration (FDA) has been steadily increasing the number of guidance documents produced on a yearly basis over the past decade. However, even with this increased pace, there are numerous topics that industry is looking to the FDA for clarity, especially newer topics like gene therapy, ...
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JournalThe health economics profile of new pharmaceuticals
The current article discusses elements of the health economics profile of new pharmaceuticals, specifically looking at the challenges of providing a healthcare system, the concepts around the provision of value-based healthcare systems and calculating the cost-effectiveness of new medicines. A quality-adjusted life year (QALY) is a concept used in health ...
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JournalHarmonising regulation of medicinal allergen products throughout the European Union – the historic situation and subsequent CMDh guidance
Allergen products in the EU are defined as goods ‘intended to identify or induce a specific acquired alteration in the immunological response to an allergizing agent’. Historically, allergens were authorised under the national frameworks of member states (MS) with some legislation pre-dating the Treaty of Rome in 1957. This led to regulatory problems, such as pharmacovigilance monitoring standards. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) addressed these authorisation issues and published a document on recommendations to common regulatory approaches for medicinal allergen products. This article provides an overview of the CMDh guidance, including a summary of some of the responses received during its consultation phase.
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FocusHow data remediation and stewardship is becoming a standard responsibility for regulatory operations professionals
Data quality is becoming increasingly critical to the success of medicinal product applications and has the potential to increase the speed and efficiency of medicines supply to patients. There is an industry move towards a data-driven regulatory enterprise, highlighted particularly through the arrival of initiatives such as identification of medicinal products (IDMP), real world evidence (RWE), digital application dataset integration (DADI), electronic product information (ePI), marketing status (IRIS), US FDA knowledge-aided assessment and structured application (KASA) and eCTD 4.0, among others.
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JournalEU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome? Part 2
Rx to over the counter (OTC) switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or general shop without a prescription. This research investigates the challenges the pharmaceutical industry has faced with this process in the European Union and proposes where improvements could be made. It is important for consumers to have direct access to medicines without a prescription as this allows time for doctors to focus on more urgent care needs. This emphasis on consumer ‘self-care’ is even more important now, during a pandemic, when face-to-face consultations with doctors have reduced.
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JournalInclusion of older people in drug development and clinical trials: Part 1
As the global population ages, older people will increasingly become the main users of medication. Much work has already been done by regulatory authorities to review legislation, leading to the 2013 publication of the EMA’s Geriatric Medicines Strategy. It reported, however, that many clinical trials still did not include a representative number of older people – aged 65 and over – despite the drugs in development were most likely to be used by this cohort. This two-article series will analyse if the publication of ICH E7 Q&A influenced the number of older people included in clinical trials. Furthermore, a qualitative questionnaire assessed the extent to which clinical trials are designed to adequately represent older people. In part one, I will focus on the legislative framework governing drug development for older patients, and the sub-classifications of age groups.
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JournalAntibiotics in biopharmaceutical production
As per the WHO, antimicrobial resistance (AMR) is a global health threat and a complex problem that requires a united multisectoral approach. In the interest of patients and environmental safety, regulators around the globe are discouraging the use of antibiotics in all areas of their utilisation ie, not only at ...
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JournalPart 1: EU reclassification (Rx to OTC switch) regulatory framework – what are the key challenges for industry and how might these be overcome?
Rx to OTC switch is the regulatory process that medicines must go through before they can be purchased in a pharmacy or shop without a prescription. This research investigated the challenges faced by the pharmaceutical industry with this process in the European Union and proposes where improvements could be made. It is important for consumers to have direct access to medicines without a prescription as this allows time for doctors to focus on more urgent care needs. This emphasis on consumer “self-care” is even more important now, during a pandemic, when face-to- face consultations with doctors have reduced.
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FocusData governance as a strategic imperative for regulatory compliance
Data governance is a multi-faceted arrangement that relies on data quality, data integrity, data and document management, security and safe storage. It is critically important to companies and regulators as they evaluate product quality, the manufacturing process and the reliability of study data from non-clinical and clinical research. The integrity ...
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JournalExploring Amgen’s Project Orbis experience with sotorasib (Part 2)
On 28 May 2021, sotorasib (LUMAKRAS™/LUMYKRAS®), a novel, first-in-class, inhibitor of the RAS GTPase family became the first drug to be approved by the US Food and Drug Administration (FDA) to target Kirsten rat sarcoma proto-oncogene (KRAS) G12C, a target that was considered undruggable for 40 years. Sotorasib is indicated ...
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JournalCMC considerations for US biosimilars development
The US Biologics Price Competition and Innovation Act of 2009 (BPCI Act) provides an abbreviated licensure pathway for biosimilar products. This pathway brought the hope of lower cost biologics, perhaps similar to what was accomplished by generics for small molecule drugs. Twelve years have now passed since the BPCI Act and experience continues to be gained with biosimilars development…
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JournalA regulatory view on the change management process for medicinal products
An effective change control process is a critical part of good manufacturing practice (GMP), during the post-approval phase of a medicinal product’s lifecycle. This article reviews key aspects of the current EU and International Conference on Harmonisation (ICH) quality guidelines. The operational aspects of the change control process are explored and guidance is provided on how the strategic review of changes can avoid or minimise the regulatory impact.
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FocusRegulatory Framework for Platform Technologies
Several novel manufacturing technologies and platforms, for example, messenger ribonucleic acid (mRNA) platform, synthetic DNA (doggybone (dbDNA)) platform, have recently emerged to produce vaccines and advanced therapy medicinal products (ATMPs) for human use. However, the regulatory framework for such platform technologies is not fully developed. There is significant interest in utilising platform approaches for drug development and for the commercial production of human medicines. Thus, some form of regulatory guidance and pathway, similar to the EU platform technology master le (PTMF) system that is used in the regulatory approval of veterinary vaccines, would benefit the human vaccines industry.
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FocusGene therapy products: regulatory expectations and challenges for industry
As the technology behind gene therapy products continues to evolve, applicants face the challenge of adapting their programmes to increasingly demanding and detailed regulation. This article provides an overview of current regulatory expectations and the challenges they may present to industry.
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JournalA review of paediatric development challenges, FDA collaboration and future trends
Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...
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FocusThe EU restriction proposal for intentionally-added microplastics: A focus on solid dosage form medicinal products and food supplements
Among the European initiatives to address the growing concern of plastics in the environment, the European chemicals agency (ECHA) has prepared a restriction proposal for intentionally-added microplastics amid concerns about plastics in the environment. An introduction to the proposal and its impact on consumer products.
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JournalBrexit: The regulatory landscape one year on
A year since the UK departed from the EU, what has changed? The UK has started to depart from the EU in a number of different ways. This article will explore what has changed, how it came about and what to look out for as the relationship between the UK and EU, as well as the rest of the world, continues to evolve.
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JournalNavigating the regulatory landscape for regenerative medicines in Japan
This is the final article in a series of three that critically analyse the differences and similarities between the regulation of advanced therapy medicinal products (ATMPs), also known as regenerative medicines…[1],[2]