• RoundupsRoundups

    Asia-Pacific Roundup: Singapore seeks feedback on planned unique device identification system

    Singapore’s Health Sciences Authority (HSA) is seeking feedback on the regulatory requirements for the planned implementation of a unique device identification (UDI) system. HSA wants to establish a harmonized identification system to enable the traceability of medical devices.   Today, HSA lacks the means to track the distribution and use of medical devices across the supply chain and healthcare system. HSA wants to gain that power to support the timely identification...
  • Regulatory NewsRegulatory News

    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 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...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Pushes to Improve Generic Drug Quality (8 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...
  • Regulatory NewsRegulatory News

    Singapore Regulator Alleges Fake Lab Report Used on Facebook Page

    Singapore’s healthcare product regulator, the Health Sciences Authority (HSA), is alleging that a Malaysian dietary supplement company used falsified lab reports when promoting one of its products on its Facebook page and blog. A Warning on Facebook The company, Champion Club International Sdn Bhd, was warned about the Facebook post by HSA in a 23 December 2014 update on the regulator's website . The update clarifies that the product in question, known as "E250," is ...