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Therapeutic Innovation & Regulatory... Mar 2023National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring...
National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring adequate efficacy, safety and quality of approved products. Additionally, common expectations include that the evaluation process is competent, flexible, commensurate with risk, efficient and rapid. In 2014, the Australian regulatory system was out of step with global regulatory developments which led to a comprehensive regulatory review and reform process. As part of the reforms, two Facilitated Regulatory Pathways (FRP) were developed for prescription medicines: Priority Review (PR) and Provisional Approval (PA). Furthermore, regulatory reliance and recognition arrangements have been expanded with the Therapeutic Goods Administration (TGA) making increased use of evaluation reports by trusted NRAs. The new pathways have been utilised by the pharmaceutical industry in Australia since 2017, with the number of medicines going through these pathways gradually increasing. Additional facilitated pathways have been developed following the review, providing alternatives to the standard pathway for registration of prescription medicines in Australia. The reform is timely, helping to position Australia well in the current global regulatory climate.
Topics: Australia; Prescription Drugs; Drug Industry; Prescriptions
PubMed: 36271207
DOI: 10.1007/s43441-022-00465-2 -
Health Informatics Journal 2021Pharmaceutical supply chain (PSC) consists of multiple stakeholders including raw material suppliers, manufacturers, distributors, regulatory authorities, pharmacies,... (Review)
Review
Pharmaceutical supply chain (PSC) consists of multiple stakeholders including raw material suppliers, manufacturers, distributors, regulatory authorities, pharmacies, hospitals, and patients. The complexity of product and transaction flows in PSC requires an effective traceability system to determine the current and all previous product ownerships. In addition, digitizing track and trace process provides significant benefit for regulatory oversight and ensures product safety. Blockchain-based drug traceability offers a potential solution to create a distributed shared data platform for an immutable, trustworthy, accountable and transparent system in the PSC. In this paper, we present an overview of product traceability issues in the PSC and envisage how blockchain technology can provide effective provenance, track and trace solution to mitigate counterfeit medications. We propose two potential blockchain based decentralized architectures, Hyperledger Fabric and Besu to meet critical requirements for drug traceability such as privacy, trust, transparency, security, authorization and authentication, and scalability. We propose, discuss, and compare two potential blockchain architectures for drug traceability. We identify and discuss several open research challenges related to the application of blockchain technology for drug traceability. The proposed blockchain architectures provide a valuable roadmap for Health Informatics researchers to build and deploy an end-to-end solution for the pharmaceutical industry.
Topics: Blockchain; Hospitals; Humans; Pharmaceutical Preparations; Privacy; Technology
PubMed: 33899576
DOI: 10.1177/14604582211011228 -
Journal of Oncology Pharmacy Practice :... Mar 2023This evidence-based practice guideline was developed to update and address new issues in the handling of hazardous drugs including being compliant with NAPRA (National...
This evidence-based practice guideline was developed to update and address new issues in the handling of hazardous drugs including being compliant with NAPRA (National Association of Pharmacy Regulatory Authorities) and USP 800 (United States Pharmacopeia) standards, the use of personal protective equipment and treatment in diverse settings including in the home setting. This guideline was developed from an adaptation and endorsement of existing guidelines and from three systematic reviews. Prior to publication, this guideline underwent a series of peer, patient, methodological and external reviews to gather feedback. All comments were addressed and the guideline was amended when required. This guideline applies to and is intended for all health care workers who may come into contact with hazardous drugs at any point in the medication circuit. The recommendations represent a reasonable and practical set of procedures that the intended users of this guideline should implement to minimize the opportunity for accidental exposure. These recommendations are not limited to just the point of care, but cover the entire chain of handling of cytotoxics from the time they enter the institution until they leave in the patient or as waste. Decreasing the likelihood of accidental exposure to cytotoxic agents within the medication circuit is the main objective of this evidenced-based guideline. The recommendations differ slightly from previous guidelines due to new evidence.
Topics: Humans; Hazardous Substances; Antineoplastic Agents; Health Personnel; Pharmacy; Personal Protective Equipment; Occupational Exposure
PubMed: 36373754
DOI: 10.1177/10781552221135121 -
Bundesgesundheitsblatt,... Nov 2020Allergen immunotherapy (AIT) is the only causally effective, disease-modifying form of therapy that, in addition to alleviating allergic symptoms, counteracts disease... (Review)
Review
Allergen immunotherapy (AIT) is the only causally effective, disease-modifying form of therapy that, in addition to alleviating allergic symptoms, counteracts disease progression.This article provides an up-to-date overview of immunological, regulatory and practical aspects of AIT. Current literature was included and recent conceptual regulatory developments from the Division of Allergology at the higher federal authority (Paul-Ehrlich-Institut) are presented.The 62 AIT products currently approved in Germany and further 61 AIT products under the development program of the Therapy Allergen Ordinance (TAO) include 95 products for subcutaneous (SCIT) and 28 for sublingual (SLIT) treatment of birch/alder/hazel pollen, grass pollen, weed pollen, house dust mite and insect venom allergies. Native and chemically modified allergen extracts (allergoids) adsorbed to aluminium, tyrosine (partly monophosphoryl lipid A-adjuvanted) or lactose or based on lyophilisates are used as active ingredients.These 123 AIT products are subject to official state batch release testing. This does not apply to named patient products (NPPs) available for the treatment of less prevalent allergies (e.g. to olive pollen, animal hair, storage mites or moulds). There is a particular need for development of AIT products for children.As a new class of active ingredients, food allergens are in clinical phase II and III studies. A first food preparation for oral AIT of peanut allergy in children is currently undergoing a central European marketing authorization (MA) procedure. MA can only be granted if the benefit-risk balance is positive. Science and regulation are in continuous exchange on the development of AIT products that correspond to the current state of clinical research and regulation in the EU and enable early causal treatment of widespread allergies.
Topics: Allergens; Animals; Asthma; Child; Desensitization, Immunologic; Germany; Humans; Pollen
PubMed: 33140209
DOI: 10.1007/s00103-020-03224-6 -
Perspectives in Clinical Research 2015The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health... (Review)
Review
The elderly population is a large and the fastest-growing portion of the population worldwide. The elderly make up the lion's share of patients for certain health conditions including cancer, cardiovascular disease, arthritis, and Parkinson's disease, among others in most parts of the world. Furthermore, elderly make up the majority of patients for many medications treating chronic conditions. Typically, clinical trials conducted in adult population include patients between the ages of 18 and 64 years. However, drugs should be studied in all age groups and trial participants should be representative of the patient population receiving the therapy in daily medical practice. Elderly patients are poorly represented in clinical trials. Hence, there is inadequate evidence and knowledge about responses of geriatric patients to medications. Regulatory authorities in developed countries urge to avoid arbitrary upper age limits and advise researchers and industry not to exclude elderly people from clinical trials without a valid reason. Since last few years Indian regulatory authority has been stipulating upper age limit for studies conducted in India. The Central Drugs Standard Control Organization (CDSCO) will be doing a great contribution to the researchers if it changes its view on stipulating upper age restrictions in clinical studies. This article describes the need for including elderly patients in the clinical trials in order to garner data from geriatric patients who form major medication users in most of the chronic diseases.
PubMed: 26623388
DOI: 10.4103/2229-3485.167099 -
Frontiers in Pharmacology 2023Considerable efforts have been exerted to implement Pharmacogenomics (PGx), the study of interindividual variations in DNA sequence related to drug response, into... (Review)
Review
Considerable efforts have been exerted to implement Pharmacogenomics (PGx), the study of interindividual variations in DNA sequence related to drug response, into routine clinical practice. In this article, we first briefly describe PGx and its role in improving treatment outcomes. We then propose an approach to initiate clinical PGx in the hospital setting. One should first evaluate the available PGx evidence, review the most relevant drugs, and narrow down to the most actionable drug-gene pairs and related variant alleles. This is done based on data curated and evaluated by experts such as the pharmacogenomics knowledge implementation (PharmGKB) and the Clinical Pharmacogenetics Implementation Consortium (CPIC), as well as drug regulatory authorities such as the US Food and Drug Administration (FDA) and European Medicinal Agency (EMA). The next step is to differentiate reactive point of care from preemptive testing and decide on the genotyping strategy being a candidate or panel testing, each of which has its pros and cons, then work out the best way to interpret and report PGx test results with the option of integration into electronic health records and clinical decision support systems. After test authorization or testing requirements by the government or drug regulators, putting the plan into action involves several stakeholders, with the hospital leadership supporting the process and communicating with payers, the pharmacy and therapeutics committee leading the process in collaboration with the hospital laboratory and information technology department, and healthcare providers (HCPs) ordering the test, understanding the results, making the appropriate therapeutic decisions, and explaining them to the patient. We conclude by recommending some strategies to further advance the implementation of PGx in practice, such as the need to educate HCPs and patients, and to push for more tests' reimbursement. We also guide the reader to available PGx resources and examples of PGx implementation programs and initiatives.
PubMed: 37274118
DOI: 10.3389/fphar.2023.1189976 -
Disaster Medicine and Public Health... Jul 2022Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency,...
Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.
PubMed: 35899949
DOI: 10.1017/dmp.2022.200 -
Vaccine Aug 2022Vaccine products represent one of the most successful public health measure to this day. This has been reflected during the current COVID-19 pandemic where more than...
Vaccine products represent one of the most successful public health measure to this day. This has been reflected during the current COVID-19 pandemic where more than 4.87 billion people have received at least one vaccine dose. In Latin America, Mexico occupies the second position in terms of the number of vaccinated people with 83.97 million people receiving at least a single dose. As in other countries, regulatory approval in Mexico is one of the key aspects that influences the public access to vaccines. This creates an active interplay between regulatory authorities establishing a regulatory framework to assure the quality, safety and efficacy of the vaccines, and applicants fulfilling this information. Mexico is a member of the International Council for Harmonisation (ICH) and it has adopted the Common Technical Document (CTD) for providing this information. This is particularly useful for vaccines developed abroad where it is expected to speed the evaluation of the new product. The Secretariat of Health of Mexico (SALUD) has published guidelines and laws or regulations related to GMP, labeling, stability, clinical trials, biocomparability and pharmacovigilance for drug products including vaccines which are classified as biological products. SALUD has also established guidelines and international homologating agreements to facilitate the application process for vaccine approval. Nevertheless, technical and scientific information and administrative processes for vaccine approval might be relatively concealed. Therefore, we aim to enable researchers and manufacturers in Mexico and overseas to better understand these requirements. To our knowledge, this is the most up-to-date and comprehensive attempt to present this information, also including information for COVID-19 vaccines. Here we describe the current requirements and processes by COFEPRIS, the national regulatory agency, for vaccine licensing and for emergency use authorization for COVID-19 vaccines in Mexico.
Topics: COVID-19; COVID-19 Vaccines; Humans; Mexico; Pandemics; Vaccines
PubMed: 35835630
DOI: 10.1016/j.vaccine.2022.07.003 -
Menopause (New York, N.Y.) Feb 2016We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone... (Review)
Review
OBJECTIVE
We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding.
METHODS
US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT.
RESULTS
Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data.
CONCLUSIONS
The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk.
Topics: Drug Approval; Drug Compounding; Drug Industry; Government Regulation; Hormone Replacement Therapy; Humans; Legislation, Drug; Therapeutic Equivalency; United States; United States Food and Drug Administration
PubMed: 26418479
DOI: 10.1097/GME.0000000000000523 -
Frontiers in Medicine 2020In recent years inhaled systems have shown momentum as patient-personalized therapies emerge. A significant improvement in terms of therapeutic efficacy and/or reduction... (Review)
Review
In recent years inhaled systems have shown momentum as patient-personalized therapies emerge. A significant improvement in terms of therapeutic efficacy and/or reduction adverse systemic effects is anticipated from their use owing these systems regional accumulation. Nevertheless, whatever safety and efficacy evidence required for inhaled formulations regulatory approval, it still poses an additional hurdle to gaining market access. In contrast with the formal intravenous medicines approval, the narrower adoption of pulmonary administration might rely on discrepancies in pre-clinical and clinical data provided by the marketing authorization holder to the regulatory authorities. Evidences of a diverse and inconsistent regulatory framework led to concerns over toxicity issues and respiratory safety. However, an overall trend to support general concepts of good practices exists. Current regulatory guidelines that supports PK/PD (pharmacokinetics/pharmacodynamic) assessment seeks attention threatening those inhaled formulations set to be approved in the coming years. A more complex scenario arises from the attempt of implementing nanomedicines for pulmonary administration. Cutting-edge image techniques could play a key role in supporting diverse stages of clinical development facilitating this pharmaceutics take off and speed to patients. The ongoing challenge in adapting conventional regulatory frameworks has proven to be tremendously difficult in an environment where market entry relies on multiple collections of evidence. This paper intention is to remind us that an acceptable pre-clinical toxicological program could emerge from, but not only, an accurate and robust data imaging collection. It is our conviction that if implemented, inhaled nanomedicines might have impact in multiple severe conditions, such as lung cancer, by fulfilling the opportunity for developing tailored treatments while solving dose-related toxicity issues; the most limiting threat in conventional lung cancer clinical management.
PubMed: 32181253
DOI: 10.3389/fmed.2020.00050