The Drug Controller General of India (DCGI) has initiated strategies to strengthen regulatory oversight of India’s pharmaceutical industry. India expects to add about 200 more drug inspectors in the coming months to build up their drug regulatory capacity. Previously, oversight of India’s... Read More
In late May 2015, the China Food and Drug Administration (CFDA) announced an increase in drug and medical device registration fees – effective immediately. The government registration fee for imported pharmaceutical products will increase to $156,500, while imported generic drugs will cost... Read More
Over the last 10 years, India has been trying to implement a Medical Device Act, without success. In early June, India’s Department of Pharmaceuticals (DOP) released a draft National Medical Device Policy (2015). The policy would create a National Medical Device Authority... Read More
Over the last few months, many foreign device companies have registered in Malaysia via the transition list. If foreign companies are not on this transition list by June 30, 2015 they will not be able to sell their devices in Malaysia for... Read More
China’s Food and Drug Administration (CFDA) recently released guidelines for the clinical evaluation of Class II and Class III medical devices. The guidelines also outline the documentation required by the CFDA. A clinical trial waiver may be granted if the device is... Read More
The Taiwan Food and Drug Administration (TFDA) has announced a registration fee increase that will be effective as of July 1, 2015. Registration fees for Class I devices will decrease slightly, while fees for Class II and III devices will increase by... Read More
Many drug companies have been reporting delays in obtaining drug product approvals and licenses in India. Not only must drug companies deal with product reviews and regulations from the Central Drugs Standard Control Organization (CDSCO), but companies also often need approvals or... Read More
The Japanese government appears to be planning annual National Health Insurance (NHI) drug price revisions from fiscal years 2016-2018 — and perhaps beyond. Pharmaceutical prices in Japan are set by the government, based on standardized formulas and negotiations with the manufacturer. For... Read More
The U.S. Food and Drug Administration (FDA) has released a set of guidance documents for biosimilars. Together, the documents outline how the FDA will assess biologic drug exclusivity, biosimilars, and interchangeability. It is expected that the changes discussed will have a significant... Read More
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced additional high risk medical device product types that must be tracked post-registration. Since late last year, importers of certain high-risk implantable devices have been required to report on the status of... Read More