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    Asia-Pacific Roundup: India lowers bar for approval of COVID-19 vaccines already authorized overseas

    India’s Central Drugs Standard Control Organization (CDSCO) has relaxed the requirements for the restricted-use emergency authorization of COVID-19 vaccines that are already on the market in some overseas territories.   The change exempts developers of certain COVID-19 vaccines from the need to run post-approval bridging clinical trials and for every batch to undergo testing at the Central Drugs Laboratory at a site in Kasauli. CDSCO is granting the exemption to vaccin...
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    Asia-Pacific Roundup: TGA consults on advertising code revamp

    The Therapeutic Goods Administration (TGA) is seeking feedback on ways to improve the Australian Therapeutic Goods Advertising Code and has proposed options for addressing provisions that it has identified as unclear or inconsistent since the current version of the code came into effect two years ago.   In the consultation document, TGA lists multiple issues with the current code that stakeholders have identified, plus options for how to remedy them. For example, some ...
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    Asia Regulatory Roundup: China Releases UDI Rules as Pilot Progresses

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Plan to List Excipients in Drug Products Online   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on plans to list the excipients in medicines online. TGA is considering enforcing the change to give consumers access to information about the products they consume.   Today, the public version of the Australian Register f...
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    Asia Regulatory Roundup: China Changes Stance on Fake Drugs and Online Sales in Legal Update

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Changes Stance on Fake Drugs and Online Sales in Legal Update   China has passed changes to the drug administration law. The revised law, which will come into force at the start of December, requires online sellers of drugs to comply with certain rules and increases the maximum fine for organizations that make and market counterfeit medicines.   The Nationa...
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    Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...
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    Asia Regulatory Roundup: China Expands Medical Device Registration Pilot to Cover Multiple Regions

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Expands Medical Device Registration Pilot to Cover Multiple Regions   China’s National Medical Products Administration (NMPA) has expanded a medical device registration pilot project. The pilot project, which began in a free trade zone, will now cover 21 provinces to help NMPA accrue more experience of the medical device registration system.   NMPA is running ...
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    Asia Regulatory Roundup: India Forms Medical Device Technical Advisory Group to Help CDSCO

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Reveals Recently Passed Order Faced Strong Industry Opposition   Australia’s Therapeutic Goods Administration (TGA) has revealed that parts of the medicines industry objected strongly to its recently adopted standard for tablets and capsules. The legislation came into effect in March despite big pharma trade group Medicines Australia arguing that, “It is unclear ...
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    Asia Regulatory Roundup: CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   CDSCO Seeks Feedback on Planned Risk-Based Pharmacovigilance Inspection Program   The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance inspections and prioritize the assessment of companies that introduce new drugs to the marke...
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    Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Strengthens Supervision of Online Drug and Medical Device Sales The China Food and Drug Administration (CFDA) has moved to strengthen oversight of online sales of drugs and medical devices. CFDA outlined its plans in a notice instructing its regional outposts to step up their monitoring of the internet and make it easier for the public to alert them of illegal a...
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    Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Guidance on Quality Control of Medical Devices China Food and Drug Administration (CFDA) has posted guidance on quality control and finished product release for medical devices. The document details the procurement control procedures, finished product inspection rules and other processes CFDA wants companies to establish to ensure medical devices meet manda...
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    Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (26 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Caps Prices of Drug-Eluting and Bare-Metal Stents The Indian government has decided to cap the prices of drug-eluting and bare-metal stents. Officials reached the decision, which follows years of debate about the subject, after a subcommittee of cardiologists recommended that coronary stents be categorized as essential medical devices.  Members of the subcommittee ...
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    India Releases New Biosimilars Guidance

    India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012 , but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes ei...