Pharmacovigilance in China
On 2017, China began the harmonization of their pharmacovigilance structure when they joined the ICH. GRP’s blog breaks down the structure of china reporting system and the requirements of a PMF.
China’s NMPA announces the 2020 Medical Device Industry Standard Revision Plan
On March 2020, China’s NMPA issued the 2020 Medical Device Industry Standards Revisions Plan. They revision produced 9 mandatory and 77 recommended standards for Medical Devices.
Japan’s MHLW Allows Online IRB Meetings for Coronavirus Trials
Japan’s MHLW issued on April 1, allowing institutional review board (IRB) meetings to be held online or via emails when urgent deliberations are needed to decide whether to approve clinical trials for COVID-19.
New Fees and Requirements for the Registration of DMFs of APIs in China
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
China’s Communist Party held a meeting on March 4 to study the current state of Coronavirus in China.
The Standing Committee of the Political Bureau of the Central Committee of the Communist Party of China held a meeting on March 4 which was presided over by General Secretary Xi Jinping to study the current priorities for the prevention and control of the novel coronavirus epidemic and the stabilization of economic and social operations
The FDA Prepares for the Fourteenth Annual Meeting International Cooperation on Cosmetics Regulation.
The FDA announces on March 3rd that they hold a public meeting regarding the 14th International Cooperation on Cosmetics Regulation (ICCR)- to be held on April 14, 2020.
PMDA Approach to Artificial Intelligence (AI) based Medical Devices
PMDA has adapted emerging technologies such as AI based medical devices and has reviewed the registration process to make it more efficient.
Accelerated Approval of Detection Reagents of Coronavirus in China
The Emergency Approval of Novel Coronavirus Nucleic Acid Detection Reagent has shown the NMPA accelerated approval of seven NAD Reagents in only four days before going to the market.
China Health Authority CDE Cancelling Face-to-Face Meetings with Companies to Prevent the Spread of Coronavirus
On February 3, 2020 China’s CDE has taken some measures to prevent and limit the spread of corona-virus out from the city of Wuhan.
HOW TO FILE A DMF FOR AN API IN JAPAN
GRP- blog explains the PMDA’s DFM application process and lists the necessary content needed for API submission to the PMDA.
NMPA PUBLISHES NEW GUIDELINE ON HOW TO ADDRESS LETTER OF DEFICIENCIES FOR MEDICAL DEVICE COMPANIES IN CHINA
On January 16, 2020 the NMPA publishes guideline explaining how medical device manufacturers should respond to a letter of deficiency from NPMA.
ONE-TIME IMPORT OF BIOLOGICAL PRODUCTS FOR CLINICAL TRIALS IN CHINA
CDE releases No. 94 of 2018 stating that certain biological products maybe imported for a one- time for clinical trial purposes.