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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: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Moves to Block Manipulation of Stent Margins, Advance Knee Implant Price Probe The National Pharmaceutical Pricing Authority (NPPA) of India has revised its rule on the pricing of coronary stents to stop manipulation of profit margins. NPPA’s addendum clarifies the definitions of “manufacturer” and “distributor” and prohibits that latter from making margins of mo...
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    Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...
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    Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Seeks Feedback on Essential Principles for Medical Device Safety and Performance India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices. Officials at the Ministry ...
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    Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (18 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pfizer, Sanofi Warn TGA Complementary Medicine Reforms Will Increase Regulatory Burdens Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathw...
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    Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Boehringer, J&J Pressure TGA to Bring ‘Out of Date’ Advertising Framework into Digital era Boehringer Ingelheim and Johnson & Johnson have called for the Australian regulator to bring its advertising framework into the digital era. The Therapeutic Goods Administration (TGA) stands accused of operating an out-of-date framework that has failed to adapt to the rise of ad...
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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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    Asia Regulatory Roundup: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (20 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal Johnson & Johnson and Medtronic have criticized the Therapeutic Goods Administration (TGA) of Australia's proposed priority review pathway for medical devices. Both companies found fault with multiple aspects of the proposal and said they are unlikely to apply for medical devices to have priority revie...
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    Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Sets Guidelines for FDC Trials as Long Wait for Phase IV Protocols Continues The Drug Controller General of India (DCGI) has outlined how makers of fixed-dose combinations (FDCs) can meet regulatory demands for clinical data on their drugs. DCGI Dr. GN Singh is asking FDC manufacturers to focus on safety data and is providing flexibility in the design of clinical...
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    Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Ordered More Inspections of Foreign Manufacturers in 2016, but Visited far Fewer Sites The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only perf...
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    Asia Regulatory Roundup: India’s NPPA Withdraws List of Pricing Rule Violators (30 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. NPPA Withdraws Lists of Alleged Violators of Pricing Rules After Industry Pushback India’s National Pharmaceutical Pricing Authority (NPPA) has withdrawn lists of drugmakers it thinks have violated its rules. NPPA published three such lists in recent months to get drug manufacturers including Abbott, Novartis and Sanofi to provide it with information, causing "discomfo...
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    Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. NPPA included the top pharmaceutical firms on a list of companies that allegedly introduced drugs without seeking price appro...