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Pharmaceutical Medicine - Regulatory Affairs 2

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BEST (Biomarkers, EndpointS, and other Tools) Resource - NCBI Bookshelf. Exclusion or exemption from risk regulation?: A comparative analysis of proposals to amend the EU GMO legislation: EMBO reports: Vol 0, No 0. International Harmonization of Drug Rules. Publication date: Jun 2, 2017 author/source: Richard Daverman, PhD China has been accepted as a member of the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).

International Harmonization of Drug Rules

The ICH is a world-wide organization, originally set up by the US, Europe and Japan in 1990 to standardize global drug regulations (approvals, good manufacturing practices, etc). The news means that China intends to continue reforms that will bring China drug regulation into line with international standards. Because of the acceptance, it should become easier for drugmakers, in China and ex-China, to bring their products across borders.

Instant China approvals for drugs from multinational pharmas are not likely to happen, any more than a Japan approval currently implies simultaneous acceptance in the US. China Joins ICH as Full Regulatory Member, Pledges to Implement Guidelines. China's Regulatory Reform and its Contribution to Global Pharmaceutical Innovation. Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) highlights the leaps and bounds with which the Chinese pharmaceutical industry has developed in recent years, the country’s increasingly important role in the global innovation landscape, and why cross-border collaboration is more crucial than ever in the time of COVID-19.

China's Regulatory Reform and its Contribution to Global Pharmaceutical Innovation

In today’s globalized world, no single country can stand alone In recent years, with the unfolding of reforms within the pharmaceutical regulatory landscape and the establishment of a more open and inclusive capital markets structure, China has been working to improve its policy environment in order to encourage pharmaceutical innovation. Accordingly, the Chinese pharmaceutical industry has advanced in leaps and bounds. As the reforms have advanced, the regulatory hurdles impeding innovation have been steadily eliminated. Made with Visme Infographic Maker. 20160302 china food and drug administration creates a prioritized drug review and approval pathway. Digital Health Apps In Europe The Road To Reimbursement Goes Through Security. By John Giantsidis, president, CyberActa, Inc.

Digital Health Apps In Europe The Road To Reimbursement Goes Through Security

Mobile digital health applications store sensitive and personal data, from pulse rate, sleep rhythm records to medication plans, as well as medical prescriptions and certificates. They connect users to appropriate services and act as communication hubs. A compromised smartphone can unintentionally disclose the entire digital life of a patient or user. Thus, establishing suitable security standards for mobile applications is critical. Two European countries have been leading the way in developing minimum security requirements for digital health applications. In September 2020, Spain’s National Cryptologic Center (CCN) issued a road map to its own minimum security requirements for digital health applications and e-health mobile apps.3 Based on the BSI guidance, these requirements are now in effect in Spain.

Purpose. Principles of benefit-risk assessment: A focus on some practical applications. In 2009 the FDA began an initiative to develop a structured method for BR assessments, and concluded that a qualitative descriptive approach could be sufficient while acknowledging that quantification of certain components of the assessment was important to support decision-making [9].

Principles of benefit-risk assessment: A focus on some practical applications

The PROTECT project (2009-2015) funded by the Innovative Medicines Initiative (IMI), was a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA) and aimed to address limitations of current methods used in pharmacovigilance and pharmacoepidemiology and to significantly strengthen the monitoring of benefit-risk of medicines marketed in Europe [10].

One of the BR methods used in the PROTECT project and applied to various case studies was the BRAT framework [11]. This is a descriptive framework, based on six main steps which are shown below [5]. DAC. DAC is the Data Analytics Centre of the Danish Medicines Agency located in Copenhagen, Denmark.


DAC will enable the Danish Medicines Agency to offer new types of scientific advice to the pharmaceutical companies on the development of new medicines, including medicines for people with rare diseases and small patient groups. About DAC. European Medicines Agency. EMA is preparing guidance on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines.

European Medicines Agency

The aim is to help medicine developers, data providers and research bodies comply with EU data protection rules, and to help patients and consumers understand their rights and the existing safeguards to protect personal data. Hma ema joint big data taskforce phase ii report evolving data driven regulation en. -National Control Laboratory Network for Biologicals (WHO-NNB)

Taking a leap towards global supply chain efficiency DIGITAL FINAL ENG. Asia regulatory conference IFPMA ARC 2020. Rwe white paper 2017. Case studies - CRC Australia. Problem Our client required a new publication for electronic platforms to communicate in a few short minutes the development of a first in class, innovative non-invasive saliva based glucose monitoring solution focused on improving the quality of life of people living with diabetes.

case studies - CRC Australia

Proposal It was essential the short piece contain key messages about the biosensor that multiple audiences could understand (e.g. consumers, healthcare professionals, investors, payers) and which were grounded on complete information and relevant insights from key speakers representing different viewpoints. Therefore, to increase audience awareness, understanding and interest in the biosensor, CRC created strategy to tell the story from ‘multiple lenses’, i.e. scientific, medical and humanistic perspectives, i.e. the biosensor inventor, the clinician and individuals with diabetes, respectively. Action Plan A six-minute video clip included the following story chapters: Examining the Impact of Real-World Evidence (RWE) on Medical Product Development : Health and Medicine Division.

At workshop 2, Adrian Hernandez, Duke University School of Medicine, presented on a suite of trials that compared novel oral anticoagulants (NOACs) to warfarin, all of which utilized RWD and consistently showed that NOACs were non-inferior to warfarin.

Examining the Impact of Real-World Evidence (RWE) on Medical Product Development : Health and Medicine Division

He posed a question for consideration: What questions characterize the use of a RWD source and signal reliability before a study is performed? At workshop 3, Jeff Allen, Friends of Cancer Research, presented a pilot project that investigated the performance of real-world endpoints among patients with advanced non-small cell lung cancer treated with immune checkpoint inhibitors. The project demonstrated that several real-world endpoints correlate well with overall survival, and showed that overall survival rates assessed from EHR and claims data were consistent with rates observed in clinical trials.

RFA-FD-20-030: Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional. Department of Health and Human Services Part 1.

RFA-FD-20-030: Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional

Overview Information Participating Organization(s) System for Evaluation of the National Regulatory Authorities for Medicines. Assessment of national regulatory authorities for medicines The process of evaluation and assessment of NRAs is based on verification of the indicators included in the data collection tool.

System for Evaluation of the National Regulatory Authorities for Medicines

This instrument is based on the recommendations of the World Health Organization for strengthening the regulatory bodies. The assessment of NRAs is based on fulfillment of critical indicators (46% of the indicators in the data collection tool). Four levels of development have been established. Level 4 is the level that enables PAHO to designate the regulatory body as a reference authority for medicines and biologicals. How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB) The MHRA will offer incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees to encourage the development of medicines in rare diseases. Waiver from scientific advice fees will also be available for UK based SMEs. See the UK Rare diseases strategy for other supportive activities.

Application process The MHRA will be responsible for reviewing applications from companies for orphan designation at the time of a marketing authorisation application (MAA). There is no pre-marketing authorisation orphan designation. How to apply Marketing Authorisation Applicants should submit the Great Britain Orphan Drug Designation Application Form (MS Word Document, 831KB) with their MAA in module 1.2 of the eCTD, specifically indicating in the cover letter their intention to seek an orphan designation.

Applications for orphan designation will be examined by the MHRA’s advisory committee, the Commission on Human Medicines (CHM). Market exclusivity period. How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB) Overcoming EU Regulatory Affairs. Regulis applies EU Regulatory Affairs expertise to rescue failing market application and delivers €3M revenue in first year sales. Situation A pharmaceutical company had submitted a marketing application for a new product seeking approval in ten EU countries. The company required a partner with specialist EU Regulatory Affairs knowledge to avoid a costly failed application. Challenge.

ERA Consulting - Useful Links. Lithuania - State Medicines Control Agency of Lithuania English Information Luxembourg - Ministère de la Santé. Ministry for the Environment. Genetic modification (GM) is a technology for altering the genetic make-up (the DNA) of living organisms so they are able to make new substances or perform new or different functions. Genetic modification is sometimes referred to as genetic engineering, or GE. Like all organisms new to New Zealand, genetically modified organisms potentially have positive or negative effects on the environment, the economy and our society.

Coronavirus Treatment Acceleration Program (CTAP) What is CTAP? FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP). The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new treatments for COVID so that we gain valuable knowledge about their safety and effectiveness. Please see our Frequently Asked Questions page for more information on the program.

Post-Coronavirus Supply-Chain Recovery. Australian Prescription Medicine Pathways – Project Orbis - Brandwood CKC. Inquiry into approval processes for new drugs and novel medical technologies in Australia. Intelligence Tools, Links and Resources — Regulatorium. Table 9. How to use regulatory technology to get deregulation right - UNSW BusinessThink. The use of regulatory technology by both regulators and the regulated requires a deep understanding of its underlying fundamentals, writes UNSW Business School’s Rob Nicholls. Harmonised Standards for MDR? CEN/CENELEC say “Non” - Brandwood CKC. Regulatory quality and COVID-19: Managing the risks and supporting the recovery. Copy the linklink copied!

Full article: A clarion call for understanding regulatory processes for additive manufacturing in the health sector. Introduction: As Additive Manufacturing (AM) in the health sector evolves to the point where products can be translated into the clinic, these manufactured goods need to be assessed by regulators in order for such products to be manufactured, sold, and used in accordance with the law. In this article, the authors argue that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. Full article: Towards understanding cybersecurity capability in Australian healthcare organisations: a systematic review of recent trends, threats and mitigation.

Walkingtheallergytightrope. EMA receives application for conditional authorisation of first COVID-19 treatment in the EU. EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Such a short timeframe will only be possible because some data have already been assessed during the first cycle of the rolling review, which started on 30 April and was concluded on 15 May. Working groups - CIOMS. Background. An Overview of the Drug Registration Requirements for Export to Tanzania, Nepal, and Cambodia.

In the semiregulated market, different countries have varying requirements of registration for export to such a specific country or region. The objective of the present study is to give a comparative overview of pharmaceutical registration requirements for export to Tanzania, Nepal, and Cambodia. In the African region especially, east Africa including Tanzania is an emerging market for pharmaceuticals. Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements. A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways. Global Pediatric Regulations: An Overview. Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation. Evaluation of the Performance of the South Africa Regulatory Agency: Recommendations for Improved Patients’ Access to Medicines.

Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview. Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation. s43441 020 00154 y. Improved Consumer Medicine Information template. Covid-19 - New REGULATIONS / GUIDANCE / NOTICES / RULES. Improving the quality of medical products for universal access. Coronavirus. Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines) A future for regulatory science in the European Union: the European Medicines Agency’s strategy.

Drug Regulation in the Era of Individualized Therapies. Janet Woodcock – Director, Center for Drug Evaluation and Research (CDER), US FDA. Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review. RegTech companies to solve compliance and regulatory issues. Regtech and NLP: What’s Next in Healthcare Regulatory Compliance - InfoDesk. "The Role Of Regtech In Augmenting Regulatory Compliance: Regulating Technology, Accountability And Liability" [2019] UNSWLawJlStuS 10; (2019) UNSWLJ Student Series No 19-10.

Tracking and Tracing Drugs and Vaccines: WHO Drafts New Policy. Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview - PubMed. FDA Finalizes 6 Gene Therapy Guidances, Unveils a New Draft. Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment. Bridging for Drug-Device and Biologic-Device Combination Products. Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry. Innovation in New Drug Approvals of 2019 Advances Patient Care Across a Broad Range of Diseases. Detailed guide regarding eudravigilance data management activities european medicines agency en. Human medicines highlights 2019 en.

Uniform recall procedure for therapeutic goods (URPTG) Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019. Medicinal cannabis for psychiatric disorders: a clinically-focused systematic review. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. TGA presentations: The 2nd Industry Forum on Good Manufacturing Practice (GMP), 21 November 2019. Regulatory and Scientific Advancements in Gene Therapy: State-of-the-Art of Clinical Applications and of the Supporting European Regulatory Framework. Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them. Regulatory Pathway for Licensing Biotherapeutics in Mexico. The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach. Uniform recall procedure for therapeutic goods (URPTG)

Scope of Improvement in the Functioning of National Regulatory Authority—A Step Toward International Accreditation: A Qualitative Study From Pakistan - Raazeyah Ikram, Anum Saqib, Irem Mushtaq, Muhammad Atif, 2019. Potential Use of Artificial Intelligence for Regulatory Intelligence: Biopharmaceutical Industry’s Views - Mark Mayer, Angelica Canedo, Tam Dinh, Madelyn Low, Ariel Ortiz, Chloé Garay, 2019. Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)

Genomics genetics transcriptomics epigenetics subgroup report en. Official web site : ICH. Heads of Medicines Agencies: HMA/EMA Joint Task Force on Big Data. Cancer medicine funding: Parallel assessment. Companion and Complementary Diagnostics: Clinical and Regulatory Perspectives - PubMed. Drug Approval Package: Onpattro (patisiran) Approves first treatment for inherited rare disease. Asia Regulatory Roundup: Pakistan Posts Draft Accelerated Approval Guidances. Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018. Badan Pengawas Obat dan Makanan - Republik Indonesia. Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies.

Enhancing consistency in wording of therapeutic indications to support healthcare decision-making. How to prepare and review a summary of product characteristics. NPR Choice page. NMPA (NMPA (CFDA)) Updates Archives - China Med Device. National Medical Products Administration. The Future of Complex Medicines: Development and Regulation. Tabling of Report on the Review into the 2016 Medicinal Cannabis amendments to the Narcotic Drugs Act 1967. Federal Court slaps online drug company with $10 million fine for marketing 'dangerous' products.

New APEC Survey: More Regulatory Approval of Medical Products.