INSIGHTS China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials
In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.VIEW MORE >
Consulting of current regulation and policy
NMPA related application for clinical trial and marketing approval
Compliance support from product development to commercialization
Post-market drug safety and risk management
Laws & Regulations Reference Listed Drug (RLD) Marketing Approval Priority Review and Approval Innovative Drugs Generic Drugs Drug Registration New DrugsHow Will China Regulate and Boost Pharmaceutical Industry by 2025 At the end of 2021, China announced its National Plan for Promoting Drug Safety and the High-quality Development of the Pharmaceutical Industry during the 14th Five-Year Plan (2021-2025). To realize the 2035 vision which includes an internationally-advanced drug regulatory system, China sets tasks to be completed by 2025.
Jan 14, 2022
Laws & Regulations CDE Guidance Reference Listed Drug (RLD) Marketing Approval Bioequivalence (BE) OTC Drugs Gene Therapy Drug Registration New DrugsMonthly Recap: China Pharmaceutical Regulatory Updates | Dec 2021 1. China Approves Its First COVID-19 Therapy; 2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels; 3. China NMPA Adjusts Over-the-Counter (OTC) Catalog; 4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs); 5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards; 6. Pharmaceutical Guidelines
Jan 13, 2022
Best-selling Ophthalmic Drugs in China | Market Wrap 2021 The year 2021 has seen a remarkable growth of the ophthalmic drug market in China. The market size of chemical drugs for eye diseases is estimated to exceed 3.5 billion yuan (circa 549 million USD), with a year-on-year growth of 1.89%.
Jan 10, 2022
Laws & Regulations Pharmacopeia MAH Pharmacovigilance Marketing Approval Priority Review and Approval Volume-Based ProcurementTop 10 BaiPharm Stories of China's Pharmaceutical Regulations | 2021 Recep ChemLinked BaiPharm Portal has been delivering and decoding China's pharmaceutical regulations to help international drug makers access the Chinese market. Here are the 10 regulatory topics that our readers are most concerned about in 2021.
Jan 07, 2022