Worldwide spending on drugs is predicted to rise by 3% to 6% per year through 2015, mainly due to the growth in developing countries such as China and India. The largest spending will remain on cancer drugs, but spending on diabetes therapies... Read More
The Indian government collaborated with the National Pharmaceutical Pricing Authority (NPPA) to evaluate the pricing of medical devices that are regulated under the Drugs and Cosmetics Act. The most noticeable finding was that these regulated medical devices can vary drastically in terms... Read More
India will soon be adopting a Common Technical Document (CTD) for the import, manufacture and marketing approval of new drugs. India’s Union Ministry of Health has produced a draft notification for the preparation of the CTD. The new format will be implemented... Read More
Japan has the second largest medical device market in the world. How you determine whether product registration makes sense is largely a function of the device reimbursement. All too often, a medical device company will go through the regulatory hurdles and long... Read More
Hong Kong’s government currently does not strictly regulate most medical devices. However, in late August 2010, Hong Kong’s Medical Device Control Office proposed a framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. The new framework draws... Read More
Since 2007, the United States Food and Drug Administration (FDA) has been working more closely with China’s primary medical regulatory authority, the State Food and Drug Administration (SFDA) to increase regulatory control of imported and exported medical goods. Regulatory harmonization deals such... Read More
The Chinese SFDA and the DOH of Hong Kong signed an agreement that details future cooperation and communication with regards to medical device and pharmaceutical regulations. The Director of the DOH Dr. P. Y. Lam and SFDA Commissioner Mr. Shao Mingli met... Read More
The US-China Joint Commission on Commerce and Trade (JCCT) Pharmaceutical and Medical Devices Subgroup meeting took place on April 13 in Chengdu, China. The Director General of the Department of Medical Devices in the SFDA, Wang Baoting, presented on the SFDA’s efforts to finalize “The... Read More
China’s State Food and Drug Administration (SFDA) officially inaugurated its Management Center for Medical Device Standards on March 30, 2010. The inauguration was held in the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP). SFDA’s Deputy Commissioner, Zhang Jingli,... Read More
Japan recently hosted the APEC Life Sciences Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) meeting on March 2-4, 2010. RHSC was established in 2008 to promote a strategic and coordinated approach to regulatory harmonization and capacity building efforts within the APEC... Read More