China’s National Medical Products Administration (NMPA) in May published adjustments to its guidelines for clinical trials of medical devices. The changes affect the process of gaining approval for clinical trials of new devices under new requirements, instituted early this year, which mandate... Read More
Seeking to encourage pharmaceutical companies to market urgently needed new drugs already approved in the United States, China’s National Medical Products Administration (NMPA) is waiving the requirement for clinical trials on 30 such therapies. The list published by the NMPA on March... Read More
Moving to speed the introduction of new pharmaceuticals to consumers, Vietnam’s Ministry of Health will exempt certain innovative drugs already tested abroad from the requirement they undergo domestic clinical trials. According to the March announcement—long hoped for by pharmaceutical firms—the ministry will... Read More
Moving to give patients faster access to new medicines, the Indian Health Ministry will waive a requirement that new drugs undergo clinical trials in India if they have already been approved in certain other markets. The New Drugs and Clinical Trials Rules,... Read More
Moving to standardize and improve its process of assessing clinical data of new in-vitro medical devices, China’s National Medical Products Administration (NMPA) in late November published new draft guidelines for IVD clinical trials. Firms either renewing or applying for new product registrations... Read More
With Singapore continuing to attract top pharmaceutical companies, clinical research and biomedical manufacturing opportunities abound. Indeed between 2000 and 2015, the number of clinical research programs conducted in Singapore jumped by 30%. Today, six out of the top 10 drugs produced globally... Read More
In an effort to streamline its drug approval process, the Chinese government will expedite the review of 48 urgently needed drugs already approved outside of China. Under these eased requirements announced in August, the China National Drug Administration (CNDA) will waive the... Read More
Renewing medical device registrations in China just became more simple. Moving to expedite the introduction of important new technologies to market, regulators announced this summer that they will require less documentation on sales data and post-market inspection reports from device makers seeking... Read More
As the pharmaceutical industry’s expansion into emerging markets meets the desire of Asian governments to speed approval of innovative products, demand for clinical trials is soaring in the Asian region. By 2021, the global market for clinical trials is expected to reach... Read More
Last month, the China National Drug Administration (CNDA), formerly known as the China Food and Drug Administration (CFDA), released a fourth batch of Class II and III medical devices that may be exempted from the requirement to conduct local clinical studies to... Read More