Recently, India has come up with the Digital Personal Data Protection (DPDP) Act, which will ensure strict data privacy rules and affect clinical trials and global capability centers (GCCs) of multinational pharmaceutical companies in the country. This law creates its standards of... Read More
On July 31, 2024, the Taiwan Food and Drug Administration (TFDA) officially launched digital GMP certificates. These certificates comply with international PIC/S GMP standards and feature advanced encryption via a digital signature recognized by Taiwan’s Electronic Signatures Act and the global Adobe... Read More
In late 2024, the National Medical Products Administration of China (NMPA) and six other government agencies published the Draft Administrative Measures for Management of Medical Representatives (Draft Management Measures) to update the 2020 Record-Filing Measures. The goal of this publication is to further... Read More
As mentioned in our earlier newsletter, Korea has implemented a new drug approval system to expedite drug approvals, which began on January 1, 2025. To do so, the MFDS has increased its fees by 50x to hire more staff, etc. However, the industry has complained... Read More
Over the last 15 years, China has been good at replicating and making good generic drugs and more sophisticated devices. Over the last few years, with the help of massive investment from the Chinese government and gobs of new local and foreign... Read More
As mentioned in our September newsletter, starting this year India’s CDSCO has issued new draft rules for its device classification catalog. Medical devices are classified at both the State and National level depending on their risk profile. Higher-risk devices (Class C and D) are... Read More
Within the China NMPA is the medical device regulatory division called the Center for Medical Device Evaluation (CMDE). The CMDE covers both medical devices and IVDs. On May 10, 2024, the CMDE issued the Announcement of the IVD Classification Catalog. This new... Read More
On December 20, 2024, the Japanese Fiscal Year 2025 NHI drug price revision was implemented. Price revisions in Japan are based on the “discrepancy rates” between the current NHI prices and the actual market prices obtained in the 2024 drug price survey. For... Read More
In late November, China’s National Health Care Security Administration added 90 new drugs to the NRDL. At the same time, 44 drugs were deleted. Now the NRDL has over 3,160 drugs, about 1,770 of which are chemical and biological drugs, with the... Read More
India’s DCGI, on January 6 revised the device classification of 4 main device categories. These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More