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  • Regulatory NewsRegulatory News

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
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    Drug Regulators Look to Harmonize How They Tackle Innovation

    The International Coalition of Medicines Regulatory Authorities (ICMRA) recently released a report on how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics, like cell and gene therapies, and new tools for drug development, such as artificial intelligence (AI). The report, which is part of a wider effort to reduce duplicative work and increase harmonization among drug regu...
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    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
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    New Research Compares Drug Regulators Around the Globe

    Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. Of the regulators in the more established major pharmaceutical markets (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such mark...
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    Asia Regulatory Roundup: India’s DCGI Asks Industry How to Further Cut Regulatory Burdens (5 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Asks Industry How to Further Cut Regulatory Burdens DCGI Dr. GN Singh has asked the industry how his agency can further reduce the regulatory burden companies face. Singh put out the call for suggestions about how DCGI can streamline drug regulation as part of a release detailing the changes it has already made to make it easier to do business in India. The ind...
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    Caribbean Regulatory System Begins Recommending Generic Drugs

    The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments. The recommendations, which follow approval from WHO, included emtricitabine/tenofovir and tenofovir tablets, also known as generic versions of Viread and Truvada (a generic of which also recently won US FDA approval ). The regional initiative is meant to help ...
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    Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways

    As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways. TGA’s priority review pathway, like Health Canada’s and FDA's  pathway with the same name , will involve faster reviews of prescription drugs ...
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    FDA Releases Guidance on Software as a Medical Device for Consultation

    The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF). Proposed Guidance According to IMDRF, the goal of the guidance is "to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]." ...
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    FDA, Health Canada Look to Implement Common Electronic Submission System

    As part of efforts to further align the US Food and Drug Administration (FDA) and Health Canada, both sides are working to implement a common electronic submission gateway to allow pharmaceutical companies to submit large electronic documents simultaneously to both regulators. The collaborative effort is just one of a number of joint action plans the two sides are planning as part of the Canada-US Regulatory Cooperation Council (RCC), which aims to increase collaboratio...
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    EMA and FDA Begin Collaborations on Patient Engagement

    The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines. The EMA/FDA teleconference, also known by EMA as a "cluster," on patient engagement seeks to increase the exchange of information on engaging with and involving patients and their organizations within the regulators’ wor...
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    Swissmedic Sees Spike in Adverse Event Reports for Third Straight Year

    In a new report on its work in 2015, Switzerland’s drug and medical device regulator Swissmedic has seen a sharp rise in the number of suspected adverse drug reaction (ADR) reports received (7.1% increase from 2014 and a more than 30% increase from 2013), due mainly to an increased volume of reports from industry. “The number of follow-ups to ADR reports is now also being recorded as a big increase in the number of reports was observed during the year and they are labour...
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    ICH Looks to Global Expansion

    The newly renamed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is looking to bring more pharmaceutical and medical device regulators into its ranks as members and observers. Begun in 1990 by EU, US and Japanese regulators as a way to further harmonize regulations on safety, efficacy, quality and data standards across the globe, with progress in developing more than 80 guidelines on such topics , as well as wor...