Data transfer in China is generally a difficult process. However, on August 30, 2024, China’s Municipal Cyberspace Administration, Municipal Bureau of Commerce, as well as the Beijing Bureau of Government Services and Data Administration, issued the “Administrative Measures for the Negative List Data Exit... Read More
The Indian government is unveiling a risk-based framework that governs the quality of imported medical devices into the country to improve safety standards. Randomized sampling will be required for the vast majority of imported medical devices, and only high-priority and diagnostic kits... Read More
In late September, Singapore’s HSA outlined a new eCTD portal program for drugs that will start in early 2025. This is an eCTD portal version 1.0, better than the previous .9 version. This new program will be in a voluntary test phase... Read More
In late July, Indonesia’s government announced GR 28 which is similar to the Indonesian Health Omnibus Law, but with more detailed explanations. This new regulation covers a number of topics. First, it states that the National Health Information System can use data... Read More
The National Medical Products Administration (NMPA) in China has released a draft Medical Device Administrative Law (MDAL) and is soliciting comments from stakeholders. The MDAL is a novel promulgation in China. A notable proposed change is the elimination of the existing country... Read More
As mentioned throughout our newsletter last year, Japan is trying to alleviate its drug lag problem and encourage more drug innovation. On a pilot basis, in an announcement in early September, the MHLW has recently noted that they will accept innovative drug... Read More
For drugs already approved in Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) under the Malay Ministry of Health, has set up a new pilot program where additional drug indications can be approved if such indications have been approved by certain foreign MOHs.... Read More
Recently, the Singapore Medical Devices Cluster promulgated a draft regulation for a Change Management Program (CMP) for SaMD products – for industry feedback. The discussion for this proposed regulation is from August 26 to October 21. Singapore, being a very advanced healthcare... Read More
On July 31, the Standing Committee in Guangdong Province promulgated a new regulation to expedite the approval of urgently needed drugs and devices into China – for products that are already approved in Hong Kong or Macao. The regulation is titled –... Read More
The Indian drug business is a huge business estimated at about $67 billion per year. Many Western drug companies rely on Indian APIs, excipients, and final drug products. Last December, the Health Ministry required all Indian drug companies to meet Indian GMP... Read More