• RoundupsRoundups

    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
  • Feature ArticlesFeature Articles

    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Looks to Join Pharma Inspection Scheme (15 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Abbott Contests Indian Allegations of Substandard Cough Syrups A dispute between Abbott and regulators in India has raised doubts about the effectiveness of the quality testing regimens implemented by local authorities. The case centers on a sample of a product branded as Abbott’s cough syrup Phensedyl that was found to contain twice as much codeine as was listed on t...
  • Regulatory NewsRegulatory News

    South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...
  • Regulatory NewsRegulatory News

    Key Changes to South Korean KGMP, IVD Regulations Set for 2015

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korean medical device regulators will implement significant changes affecting compliance requirements for  in vitro  diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015. According to Emergo consultants in Seoul, officials at the South Korean Ministry for Food and Drug...
  • Warning Letter Claims South Korean Device Company Failed to Implement Promised Changes

    A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection. The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA). During that inspectio...
  • South Korean Regulators Increase Online Data Transparency

    • 31 May 2012
    South Korea's Korean Food and Drug Administration (KFDA) has announced the re-launch of its website, which now includes consolidated drug information covering all drugs manufactured in South Korea. The website now features a sub-page, drug.kfda.go.kr , which allows for the public to "retrieve and utilize a variety of drug information," including drug safety, drug effects, drug development assistance, information on pharmaceutical excipients, drug use and more. Additiona...
  • South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh

    South Korea is moving to quickly strengthen its import controls after encountering repeated attempts to smuggle in drug products containing the powdered remains of deceased human flesh, reports The Korea Times . "The Korea Customs Service (KCS) said it apprehended 29 smugglers, who disguising themselves as tourists and attempted to bring some 11,000 capsules into Korea in their luggage," wrote The Korea Times . "Six people used international parcels to smuggle in the m...