On July 27, in an effort to reinforce the management and use of pharmaceutical products in many fields, the National Healthcare Commission (NHC) issued the Notice on Further Strengthening Medication Safety Management and Improving the Level of Rational Medication. This notice put special emphasis on pediatric... Read More
The recent amendments of the Japanese Act on the Protection of Personal Information (AAPI) have implications for healthcare businesses. According to the amendments, companies/health institutions are not allowed to transfer personal data overseas. Transfer of data outside of Japan is only permitted under special circumstances.... Read More
Although Singaporean medical practitioners were allowed to import unregistered medical devices for use on their patients with approval from the HSA, there have not been specific guidelines on this issue until this August. According to this recently issued guideline from the Health... Read More
In order to facilitate the development of new drugs, Japan’s Ministry of Health, Labor, and Welfare (MHLW) is seeking an increased budget for its Orphan Drug Designation program. In order to obtain this designation in Japan, orphan drugs need to fulfill certain... Read More
As mentioned in previous newsletters, foreign drug and device companies can gain quicker access to China’s healthcare markets if they first register their products either on Hainan Island or in the Greater Bay Area. On Hainan Island, hospitals can apply for unregistered... Read More
Last month, Singapore’s HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs... Read More
While RWE is fairly prevalent for US and EU drug companies in their home markets, this has not been the case in Japan. However, according to a recent McKinsey article, this will change in the near future and become a more common... Read More
Recently, the Filipino FDA issued a new circular that will guide companies that import, distribute, manufacture, or sell medical devices. Issues are outlined on topics including shipping out products first that are close to the expiration date, first items into storage are... Read More
Korea plans to increase its drug and biotechnology markets by adopting more global standards, implementing positive regulatory policies and increasing investment. The Korean government hopes to develop a super fund to support its vaccine and new drug development. First, Korea will set... Read More
On June 1, 2022, Japan’s PMDA’s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest... Read More