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    Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Prepares for Joint National-State Inspections of Manufacturing Plants India has laid the groundwork for joint inspections of drug manufacturing plants by officials from national and state regulatory agencies. Officials will conduct joint inspections whenever a facility seeks a license to make or sell drugs and at risk-determined intervals to check ongoing compli...
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    Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australian Generic Medicine Work-Sharing Trial Misses Completion Target A work-sharing group involving Australian regulators has reported the results of its first collaborative assessment of a generic medicine. The review of the filing took about nine months, four months longer than the collaborators had targeted at the start of the project. Officials from Australia’...
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    Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pakistan Proposes Strengthening Quality Control Unit Requirements Pakistan is planning to strengthen the requirements it places on the quality control departments of drug manufacturers. The revised legislation raises the minimum level of experience required to run a quality control unit and mandates the appointment of an independent head of quality assurance. In its curren...
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    Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA to Tighten Regulation of Autologous Cell Products, Ban Advertisements The Therapeutic Goods Administration (TGA) is planning to tighten oversight of autologous cell and tissue products. TGA’s proposed changes will bring some therapies under the biologicals regulatory framework, ban direct-to-consumer advertising and generally move Australia more in line with the ...
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    Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Tightens Stem Cell Guidelines to Curb ‘Rampant’ Unethical Therapeutic Practices India has tightened its guidelines on the banking and therapeutic use of stem cells in response to “rampant unethical practices.” The updated guidelines strengthen mechanisms for the review and monitoring of stem cell clinical trials and prohibit commercial banking of most biological ...
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    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: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Orders J&J, Other Device Makers to Maintain Output of Knee Implants The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in ...
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    Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. The Therapeutic Goods Administration (TGA) of Australia has released guidance and a web-based tool to help companies file good manufacturing practice (GMP) clearance applications. TGA created the resources to further its attempt to improve the application process and prevent the issues that contributed to the lengthening of processing times. In moving from the 17th to 18th ...
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    Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Reports 64% Year-on-Year Increase in Regulatory Compliance Investigations The Therapeutic Goods Administration (TGA) of Australia has reported a 64% increase in regulatory compliance investigations. The year-on-year jump led TGA to issue close to 2,000 warnings, almost twice as many as in the previous reporting period. TGA completed 2,887 investigations in its 2...
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    Asia Regulatory Roundup: TGA Takes Tougher Line on Incomplete GMP Clearance Applications (12 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Takes Tougher Line Against Incomplete GMP Clearance Applications The Therapeutic Goods Administration (TGA) is set to adopt a tougher line against companies that fail to submit complete good manufacturing practice (GMP) clearance applications. TGA’s revised policy strips applicants of the opportunity to submit outstanding supporting evidence before their filing ad...
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    Asia Regulatory Roundup: Drugmakers Push Back on Data Requirements in Australia’s Provisional Approval Pathway (5 September 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Big Drugmakers Push Back Against Quality Data Requirements in TGA Provisional Approval Plan A who’s who of leading drugmakers have raised concerns about the proposed data requirements for Australia's provisional approval pathway. The concerns center on the potential for the need to provide months of stability data and achieve good manufacturing practice (GMP) clearance...
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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...