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    Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DTAB Proposes Stipulations to Indian Plan for Permanent Licenses The Indian Drugs Technical Advisory Board (DTAB) has given its conditional support to end the need to renew licenses to make, sell and test drugs. DTAB is broadly in favor of the idea, but has suggested stipulations that are more burdensome than those proposed by the Drug Controller General of India (DCG...
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    Asia Regulatory Roundup: TGA Consults on Accelerated Assessments for Devices (22 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Consultation on Accelerated Assessments of Medical Devices The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on a planned priority review pathway for medical devices. TGA is asking the industry to comment on its proposed criteria for awarding priority review status, the timeframes device developers on the pathway will face and its...
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    Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Sanofi Clinical Trials Among Those Verified by CFDA China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative. The list of drugmakers to go through the data verification proc...
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    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
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    Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Clinical Data Probe Triggers Investigations Into 11 Trial Sites, CROs China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new ...
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    Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Proposes Change to Rare Disease Threshold in Orphan Drug Rethink The Therapeutic Goods Administration (TGA) of Australia is proposing to change its definition of rare diseases as part of an overhaul of its orphan drug regulation. If implemented, the revised regulations will allow drugs that treat more common diseases to qualify for orphan medicine status, but only...
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    Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...
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    Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Starts Consultation on Planned Adoption of 10 EMA Guidelines The Therapeutic Goods Administration (TGA) of Australia is seeking feedback on its plan to adopt 10 European Medicines Agency (EMA) guidelines. Most of the documents are replacements for existing EMA texts previously adopted by TGA, but some, such as guidelines on clinical development of drugs agai...
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    Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CRO Complaints About Online Portal Prompt CDSCO to Convene Meeting The Deputy Drugs Controller of India (DDCI) has convened a meeting to discuss sponsor and contract research organization (CRO) complaints about the Sugam online portal. Sponsors and CROs made the complaints after encountering problems when trying to use Sugam to apply for regulatory clearances regar...
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    Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Recalls of Medical Devices China Food and Drug Administration (CFDA) has released draft guidance on the recall process for medical devices. The text establishes who is responsible for detecting possible defects with medical devices, the process for alerting users of a fault and the penalties CFDA will hand out to companies that fail to mee...
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    Asia Regulatory Roundup: CFDA Revises Preclinical Guidance (23 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Revises Guidance on Preclinical Studies China Food and Drug Administration (CFDA) has released revised draft guidance on preclinical studies for consultation. The text sets out CFDA’s expectations for the gamut of factors that go into running preclinical studies, from the skills and responsibilities of laboratory staff to the design of facilities. CFDA established i...
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    Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Promises to Punish Clinical Trial Fraud, Outlines Vision for Future of Drug Regulation Chinese regulators are working with the legal system to ensure clinical trial data fraud is punished in the courts. The initiative, which is a near-term priority for officials, forms part of China’s vision for the development of its drug regulatory system between now and 2020. Chi...