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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guide to Implementing Revised Vaccine Distribution Regulations China Food and Drug Administration (CFDA) has released a guide to the implementation of its revised vaccine procurement and distribution regulations. The updated policy calls for vigilant record keeping by organizations in the supply chain and stronger regulatory oversight of each step in the pr...
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    Asia Regulatory Roundup: CFDA Revises Guidance on Device Trials (29 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Introduces Revised Guidance on Clinical Trials of Medical Devices China Food and Drug Administration (CFDA) has introduced a good clinical practice (GCP) document covering medical devices. The text describes how CFDA expects sponsors and other organizations to handle aspects of medical device trials, from the initial preparations through to the maintenance of da...
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    Asia Regulatory Roundup: India Reverses Opposition to Off-Label Ophthalmic Use of Avastin (15 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Reverses Opposition to Off-Label Ophthalmic Use of Avastin India has quickly reversed its opposition to the off-label ophthalmic use of Roche’s Avastin (bevacizumab).  Drug Controller General of India Dr. GN Singh warned against using Avastin in ophthalmology conditions in January after reports linking it to loss of vision emerged, only to withdraw the alert th...
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    FDA Plans New Regulation on Fixed-Dose Combinations, Co-Packaged Drugs

    • 22 May 2015
    • By
    The US Food and Drug Administration (FDA) plans to release two new regulations by the end of 2015, it announced this week. The announcement, contained in the latest edition of the US Unified Agenda , contains 33 proposed and final rules FDA says it hopes to publish by the end of calendar year 2015. In practice, however, some rules have remained on FDA's Unified Agenda for years. FDA's latest update of the Unified contains two additional regulations compared to its las...
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    EMA Drafts New Clinical Development Guideline for Fixed Dose Combination Drugs

    In response to a rise in the use of fixed dose combination (FDC) drugs, the European Medicines Agency (EMA) has revised its guideline addressing the clinical development requirements for FDCs. Background FDCs—or drugs containing multiple active ingredients—are used to treat a variety of medical issues, ranging from the common cold to tuberculosis and HIV. For many treatments, combining multiple active ingredients can result in a simpler, more effective treatment regime...
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    When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

    New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is. Background Under existing rules administered by the US Food and Drug Administration (FDA), not all new drug products are treated the same. New chemical entities (NCEs) that have never before been approved in the US for any indication are eligible for five years of marketing exclusivity, during wh...
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    New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

    The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination  (FDC) drugs consisting of at least one new drug product to be eligible for five years of so-called "New Chemical Entity" (NCE) exclusivity. But in a setback for companies with existing FDCs, the agency will not apply the policy retroactively. Background In the US, pharmaceutical manufacturers who obtain approval to market a "new" drug from...
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    Indian Regulators Say Older Fixed-Drug Combinations Can Stick Around Under New Rules

    India’s Central Drugs Standard Control Organization (CDSCO) has issued a notice exempting certain Fixed Dose Combination products (FDCs) from a requirement to submit data in support of safety and efficacy as long as they were licensed for marketing by State Licensing Authorities prior to 21 September 1988.   The 5 June 2014 decision to exempt these FDCs from the scope of the CDSCO’s 15 January 2013 mandate was based on the fact that the products were licensed bef...