• Regulation of Surface Disinfectants in Malaysia
    August 12, 2021 Chemicals, Regulatory Affairs

    With the outbreak of the global pandemic, Malaysia continues to fight the war against COVID-19. This period has been overwhelming for both the Malaysian Pharmaceutical industry as well as the consumers. As public and personal hygiene became the first defense against the virus, change in consumer behavior has been observed, especially regarding hygiene-related products in the Malaysian market...

  • FDA Guidance for Manufacturing Hand Sanitizers
    May 8, 2020 Regulatory Affairs

    The outbreak of coronavirus has become a global threat. With gradual spreading and increase in the number of infected persons, the COVID-19 has created a state of Public Health Emergency. To overcome this pandemic and ensure the safety of people, life sciences manufacturers all over the world are working continuously towards developing vaccines and solutions.

  • Draft IVD Clinical Trials guidance from NMPA in China

    National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018.