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  • RoundupsRoundups

    Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies   Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.   Work to update the law ...
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    Asia Regulatory Roundup: Pakistan Seeks Expert to Help Harmonize Regulations With Global Best Practices

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   New Zealand Extends Timelines for Reporting Medical Device Adverse Events   The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has given companies more time to report adverse events involving their medical devices.   Under the old rules, manufacturers of medical devices had seven calendar days to report incidents of actual or potential death...
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    Asia Regulatory Roundup: TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Offers Advice on Managing Shortages Triggered by Ranitidine Recalls   Australia’s Therapeutic Goods Administration (TGA) has advised physicians about how to manage the shortages created by recalls of ranitidine medicines. The notice follows decisions by eight companies to recall batches of ranitidine medicines in response to contamination concerns.   TGA firs...
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    3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

    As part of a project on emerging technologies, six regulators involved in the International Coalition of Medicines Regulatory Authorities (ICMRA) recently published a case study delving into the challenges of regulating 3D bio-printed products. In this hypothetical case, the regulators evaluated 3D bio-printed knee meniscus tissue and discussed how they would tackle similar products. The case study was conducted by Australia’s Therapeutic Goods Administration (TGA), Bra...
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    Asia Regulatory Roundup: Australia Suspends Sales of Eight Breast Implants After Safety Review

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Suspends Sales of Eight Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) has suspended the sale of eight breast implants after finishing its review of the safety of the product class. The action gives affected manufacturers a chance to meet patient safety requirements, but TGA thinks there are likely grounds to perman...
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    Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Adopts Risk-Based Model for Fecal Microbiota Transplants   Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.   The model...
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    Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs   Australia’s Therapeutic Goods Administration (TGA) has aligned its requirements for sartan medicines with those adopted in Europe. The action coincided with news from Singapore about the presence of N-nitrosodimethylamine (NDMA), one of the key sartan impurities, in GlaxoSmithKline’s Z...
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    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
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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 ...