A recent study by a research department at the Japan Pharmaceutical Manufacturer Association (JPMA) outlines how many Japanese and foreign drug companies are not increasing (and in some cases decreasing) their investment and focus in Japan’s drug market. One of the many... Read More
On November 4, the NMPA released a draft regulation entitled “Announcement on the Administration of Chemical API Registration Renewal” and is seeking public comments by December 3. The announcement and regulation is expected to go into effect in one year. Before the... Read More
In November 2018, Malaysia’s Medical Device Authority (MDA) issued the third edition of their Change Notification for Registered Medical Devices. On November 2 this year, the MDA updated this notification. The new updated version includes two main new sections – Clause 5.8... Read More
In late October, India’s Ministry of Health and Family Welfare has set up a committee to put together an extensive drug database. The committee will initially include 7 people. The goal of the drug database will be to provide an exhaustive record... Read More
Recently, the Korean Ministry of Food and Drug Safety (MFDS) issued new device renewal requirements. For renewals, the medical device in Korea cannot have had any serious adverse events, and there needs to be a production or import track record and documentation.... Read More
According to the new Administrative Measures for Drug Recalls issued on October 26, 2022, Marketing Authorization Holders (MAHs) of drug products are responsible for drug recalls, not drug manufacturers. More specifically, hospitals, drug makers, and drug suppliers are only responsible for helping... Read More
Over the last few months, Japan has upgraded regulations for labeling for medical devices and pharmaceuticals. In mid-September, Japan promulgated new regulations for regenerative products outlining the labeling requirements on containers for – 1. individual unit packaging, 2. the unit of packaging... Read More
By this past October, device manufacturers and importers of Class A medical devices in India are required to register their products via an online portal. The manufacturer or importer will also need to confirm that their device meets the requirements of the... Read More
Starting on November 1, 2022, China’s NMPA will issue electronic drug certificates for marketing authorization, clinical trials, drug renewals, chemical APIs, etc. The electronic certificate will be as valid as a paper certificate. To be eligible for electronic certificates, drug applicants must... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) recently announced a new program titled – Global Innovative Products on Fast Track (GIFT) which is similar to the US FDA’s breakthrough therapy designation system. The GIFT program is in addition to the already... Read More