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…
China pharmacovigilance regulations have been undergoing significant reform reinforced by recently issued Good Pharmacovigilance Practices (GVP) (2021, Decree No. 65). In addition to the regulations, the National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE) and National Centre for Adverse Drug Reaction (ADR) Monitoring (NCADRM) of China have also released guidelines and standards for…
China Drug Master File (DMF) for APIs, packaging Materials, and pharmaceutical excipients are regulated by China NMPA formerly CFDA. The related DMF regulations and standards clarify the drug master file structure, process, requirements, timelines, and costings in the regulations listed below. Contact Accestra Consulting Group for English translations or questions on China’s Drug Master File…
Accestra Consulting Group has put together the top 10 most asked questions and answers to China’s clinical trial exemption and IND application (CTA). China’s Center for Drug Evaluation (CDE) allows a drug Marketing Authorization Holder (MAH) to apply for clinical trial exemption in China if a drug is already approved for marketing in…
