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  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal   China is planning to introduce a risk-based regulatory system for cell and gene therapies in the wake of the germline modification scandal. The system would require developers of high-risk therapies to get state-level clearance for clinical trials, while leaving local authorities to sign o...
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    Asia Regulatory Roundup: Roche Cancer Drug First to Win TGA Priority Review Status (29 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Draft Drug Data Management Practices for Consultation The China Food and Drug Administration (CFDA) has detailed the data management standards it expects companies to follow when researching, developing, making, distributing and monitoring the use of medicines. The rules hold senior management responsible for the reliability of data. CFDA set out its exp...
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    Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Nine Months After Deadline Passed, No Manufacturers Have Complied With DCGI GMP Request The Drug Controller General of India (DCGI) has repeated his demand for manufacturers to assess the quality of their facilities and submit the resulting reports. DCGI Dr. GN Singh made the original request one year ago, but is yet to receive good manufacturing or laboratory practice...
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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...
  • Asia Regulatory Roundup: CFDA Increases Drug Regulation Budget by 31% (11 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Tells Manufacturers to Review Quality Systems to Ensure Data Integrity The Therapeutic Goods Administration (TGA) of Australia has told manufacturers to review their quality systems and the effectiveness of their data management and integrity controls. TGA made the request in a post detailing its intent to step up its focus on data management and integrity. Offici...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Security of Connected Devices (31 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Security of Connected Medical Devices China Food and Drug Administration (CFDA) has released guidance on the security of connected medical devices. The guidance details the factors companies should consider when seeking to register a device with data storage and exchange capabilities for sale in China. CFDA is aiming the guidance at Class II and...
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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: 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: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Orders Manufacturers to Assess Their Compliance with GMPs, GLPs The Drug Controller General of India (DCGI) has ordered companies to self-assess their compliance with good manufacturing and laboratory practices (GMPs/GLPs). DCGI is demanding manufacturers carry out the self-assessment, award themselves a quality rating and submit the resulting report to the relev...
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    Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Allows Parallel Submission of Clinical Trial Filings for Insulins, mAbs The Drug Controller General of India (DCGI) has cleared clinical trial sponsors to submit applications to his office and the Review Committee on Genetic Manipulation (RCGM) simultaneously. By moving from sequential to parallel filings, DCGI has potentially shortened the time it takes for de...
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    Asia Regulatory Roundup: China’s Anti-Corruption Agency Chides CFDA Over Loopholes (7 June 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China’s Anti-Corruption Agency Criticizes CFDA Over Regulatory Loopholes An inspection of China Food and Drug Administration (CFDA) by the country’s anti-corruption agency has led to the publication of a litany of alleged failings at the regulator. The graft group is calling for CFDA to standardize its review, approval and inspection processes to eliminate the “many loopho...