To learn more about how PBM can help you register your drug products in Singapore, please contact us. Introduction An island nation of 5.4 million people, Singapore is considered one of the most developed pharmaceutical hubs in Asia. With its current market size... Read More
Please feel free to contact us to obtain more information about Japan DMF. Drug component manufacturers of APIs, excipients, and drug packaging materials who want to protect their intellectual property and manufacturing processes may want to pursue a Japanese Drug Master File... Read More
On July 10, the Japanese MHLW outlined a plan to increase the number of products allowed to apply for Orphan Drug Designation (ODD) and permit this designation earlier in the drug development process. Currently, Japan only accepts orphan drugs that are for... Read More
In 2021, China’s Patent Linkage regulation went into effect, and both the Chinese National IP Administration (CNIPA) and Beijing IP Court have the responsibility for determining patent linkage. To date, the Beijing IP court has reviewed over 12 patent linkage cases, and... Read More
Recently, China’s NMPA has started to implement more programs for drug safety. Drug supervision has increased, and the number of crackdowns has jumped dramatically. Last year, there were about 160,000 regulatory investigations of false drug claims, inoperative medical devices, and other problematic... Read More
In the past, API regulations in Singapore have been governed by the Poisons Act 1938 and the Medicines Act 1975. Under the Medicines Act, wholesalers and importers of APIs are recommended to apply for GMP certification, and under the Poisons Act, they... Read More
Contact us today for a free consultation with a Japan regulatory affairs consultant to discuss your specific needs. One of the key issues in getting drug approval in Japan is to meet Japanese GMP standards. To register a drug in Japan, foreign drug... Read More
On June 16, the PMDA steering committee announced that in April 2024 or shortly thereafter, the PMDA will open offices in the US and Southeast Asia. Likely locations for these offices are Washington DC and Bangkok, Thailand – although this is not... Read More
China issued draft “Implementing Rules” for HGR in March of 2022. On June 1st, 2023, the draft implementing rules are no longer in draft and will become enforced on July 1st, 2033, according to China’s Ministry of Science and Technology. While there... Read More
Everyone knows that the China drug market is very large. However, national and provincial tenders, Volume Based Procurement (VBP), the DRG system and other recent measures have significantly lowered pricing and reimbursements. To get drug reimbursement in China, a company needs to... Read More