Changing of API registration in China NMPA- What you need to know
On January 17, 2020 The Center of Drug Evaluation has published a Notice on improving the relevant functions of the API registration system,
NMPA’s UDI Requirements in China for Medical Device Manufacturers
NMPA had issued rules for Medical Device identification under Order 66, released in October 2019, which states that medical devices marketed in China shall comply with UDI regulations and implementation plan.
China’s CMDE announces new regulations on the supervision and adminstration of customized medical devices for clinical trials.
China’s CMDE Announces new Regulations on the Supervision AND Administration of Customized Medical Devices for Clinical Trials
Drug Master File (DMF) in China
The new system set up by the NMPA allows manufacturers to file the DMF directly, thereby reducing the approval time and respective cost involved.
China Expediting the Review and Approval of Drugs to Treat Life Threatening Diseases
Chinese health authority published a list with 48 orphan drugs that qualify for an expedite review process of their registration application. The 48 drugs are used for the treatment or prevention of rare and life-threatening diseases, and have alread…
New Program for the Review of Innovative Medical Devices in China
The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program that will take effect December 1, 2018. The new NMPA policy, Order 83 [2018] includes three major changes: Applications for Innovative Devices must be submitted to NMPA within five years of patent publications; Application review timeframes will […]
CFDA Announced Major Changes to Chinese Medical Device Regulations in favor of Foreign Manufacturers
China Food and Drug Administration (CFDA) proposed major changes to medical device regulatory requirements by amending Order No. 650. The timeframe for the implementation of such changes has not been announced by CFDA yet, but foreign medical manufacturers are welcoming the new changes as they will address the major issues they are facing while registering […]
China New Policy Pushing Generics over Brands
On Tuesday April 3rd, 2018, the Chinese government published a new policy that promotes the usage of generics over brands in China. As an incentive, the qualified generics companies will be considered as high-tech enterprises, and therefore will be imposed a corporate tax rate of 15% instead of 25%. Additionally, generic that pass the quality […]
CFDA New Clinical Data Requirements for Foreign medical devices
CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]
CFDA Proposes Draft Lowering Barriers for Foreign Drug Manufacturers
In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing Multinational Companies to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines. The changes affect the following areas: 1) For imported chemical drugs and […]