Mandatory GACC registration for all F&B exporters from 1 January 2022 On 8 December 2021, the EU SME Centre and its leading consortium partner, the China-Italy Chamber of Commerce, held their webinar on new major regulations from the General Administration of Customs of China, which require all overseas F&B manufacturers exporting to China to have…
Date: Wednesday, 8th December, 2021 Time: 4 – 5:30 (Beijing） Time: 9 – 10:30 AM CST (Brussels) Price: Free of charge Click here to register. You will then receive an invitation to this webinar. Please note that the number of participants is limited. TOPICS and SPEAKERS: In April 2021, China’s General Administration of Customs (GAC)…
What is the deadline for GACC self-registration? All overseas food manufacturers and exporters to China must be registered with the General Administration of Customs of China (GACC) by deadline January 1st,2022 to avoid risk of Customs clearance delays or trade disruptions. Who needs to register with GACC? The requirements are applicable to imported food manufacturers…
China DMF Inactive Number by CDE. Complete but not approved. China DMF Active Number by CDE. Activated/Approved. For Drug master filing (DMF) in China, there is a new guideline released by China’s NMPA (Formerly CFDA) in 2019 for the scope of active pharmaceutical ingredients (APIs), excipients and packaging materials. Similar to the systems of…
To export a generic drug to China market, you need an Abbreviated New Drug Application (ANDA) for submission to China Center of Drug Evaluation (CDE) of National Medical Products Administration (NMPA formerly CFDA) for marketing authorization. Highlights of China’s New Regulations for ANDA Submission The requirements for China ANDA submission have changed and…
Part 3. Administrative Approval and Fast Track Review Pathways Table of contents Administrative approval. Fast track review pathways. 2.1. Specialized pathway. 2.2. Breakthrough therapy. 2.3. Conditional approval. 2.4. Priority Review. In 2020 CDE approved: 1,435 Investigational New Drug (IND) applications, 208 New Drug Applications (NDAs), 918 Abbreviated New Drug Applications (ANDAs). This includes 59…
Part 2. Chemical Drugs, Biological Products and Traditional Chinese Medicines Table of contents 1. Chemical Drugs. 1.1. Application Overview. 1.2. Approval. 2. Biological Products. 2.1. Application Overview. 1.2. Approval. 3. Traditional Chinese Medicine. 3.1. Application Overview. 3.2. Approval. Despite severe challenges from the COVID-19 pandemic, the Center for Drug Evaluation (CDE) of China reviewed…
Table of contents 1. Summary. 2. Technical Review & Approval. 3. Reason For Application Rejections. 3.1 New Drug Application Rejections. 3.2 ANDA Rejections. 3.3 Supplementary Application Rejections. 3.4 Other Application Rejection. In 2020, the Center for Drug Evaluation (CDE) of China reviewed and/or approved 11,582 drug registrations. To summarize the accomplishments and failures of…
