On July 8, the Indian government issued new legislation to get shareholders’ feedback. This legislation started in 2016 and is trying to replace the Drugs and Cosmetics Rules of 1945. New definitions for investigational new drugs, medical devices, clinical trials, etc. were included. New severe penalties... Read More
On June 28, the NMPA said it plans to improve services to foreign medical companies. Primarily, this message is to further help foreign drug and medical device companies with more efficient product registration. Their focus will be primarily on the pediatric and rare disease... Read More
On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a... Read More
RWE or real-world data are now becoming more important for drug and medical device approvals and reimbursement in China. Since 2019, when Hainan Island released regulations emphasizing the value of RWE, similar RWE regulations have also been issued by the NMPA for... Read More
Many Western medical companies are coming out with unique software with healthcare applications. Some stand-alone software programs in Japan are classified as program medical devices. Program medical devices generally include a computer program (intangible) or tangible recording media (any magnetic tape, disk, or other... Read More
Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up... Read More
On April 11, the NMPA issued a new Circular on year-end drug annual reporting. China MAH’s must submit 2021 annual reports by August 2022. However, after this year, annual reports must be submitted by the end of April each year. The circular... Read More
The Thai FDA will now evaluate device approval more efficiently if the device has been already approved in Singapore. This also applies to Class B-D IVD’s approved in Singapore. Basically, the Thai FDA will reduce their review time from 150 to 60... Read More
The Indian CDSCO is now discussing the need to test more devices locally to obtain Indian medical device approval. Recently, a task force has been established to determine what needs to be done to increase India’s testing facilities. Various categories of medical... Read More
Most medical devices require registration in Malaysia. Registrations are good for 5 years, and many companies are now facing re-registration. In June, the Malay Medical Device Authority released the new re-registration guidelines. Re-registration applications must be submitted via the MeDC@St application system.... Read More