Editor's Notes: Monthly recap is a collection of recently-issued drug laws, regulations and policies in China.
1. China Approves Its First COVID-19 Therapy
On Dec. 8, 2021, Brii Biosciences' Amubarvimab/Romlusevimab Combination received National Medical Products Administration (NMPA)'s approval as the first COVID-19 neutralizing antibody combination therapy in China.
The therapy is approved for treating adults and pediatric patients (aged 12-17, weighing ≥ 40kg) with the mild or normal type of COVID-19 at high risk of progression to severe disease, including hospitalization and death. The indication of pediatric patients is under conditional approval.1
2. China to Decide Whether to Conduct Pre-Approval Inspections Based on Risk Levels
China's Center for Drug Evaluation (CDE) will decide whether to carry out pre-approval inspections based on the risk level of drug registration applications.2
High-risk applications, including new drug applications (NDAs) for innovative/improved new chemical drugs, will be subject to pre-approval inspections if submitted after Jan. 1, 2022. [Read More]
3. China NMPA Adjusts Over-the-Counter (OTC) Catalog
In December 2021, NMPA transformed Dextromethorphan Hydrobromide Tablets and other ten drugs from OTC to prescription status. NMPA also added five drugs, including Felbinac Gel, to the OTC Drug Catalog. Check out the new inclusions at BaiPharm Database.
4. China NMPA Releases the 49th Batch of Reference Listed Drugs (RLDs)
The 49th batch includes 52 drugs, such as GSK's Albuterol Sulfate Syrup and Novartis' Diclofenac Sodium Sustained-release Tablets.3 RLDs are reference products which are used as new generic drugs' counterparts to demonstrate bioequivalence. Find out details at BaiPharm Database.
5. For Medical Devices: Class I Catalog, Emergency Approval Procedures, and Industry Standards
The new Catalog of Class I Medical Devices issued by China NMPA came into effect on Jan. 1, 2022. Class I Medical Devices are considered to have low risks. For them, filing instead of registration is required. Compared with its 2017 version, the catalog no longer includes in vitro diagnostic (IVD) reagents or products combined by more than two medical devices.4
On Dec. 30, 2021, NMPA issued the Procedures for Reviewing and Approving Medical Devices for Emergency. According to this regulation, in order to tackle emergencies immediately, NMPA will complete technical review for eligible medical devices within 10 workdays5.
Besides, China released a list of 19 new or revised industry standards for medical devices such as multiplex nucleic acid test kits for respiratory viruses.
6. Pharmaceutical Guidelines
Guidelines for Pharmacovigilance Inspections (Consultation Draft)
Guidelines for Reviewing Clinical Trial Applications for Non-original Companion Diagnostic Reagents for Antineoplastic Drugs
Guidelines for Reviewing In Vitro Diagnostic Reagent Registration Applications Which Used Overseas Clinical Trial Data
ICH Q3C(R8) Impurities: Guideline for Residual Solvents (adopted in China)
Technical Guidelines for Clinical Research on Long-term Follow-up of Gene Therapy Products (Trial)
Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products (Trial)
Technical Guidelines for Non-clinical Research on Genetically-modified Gene Therapy Products
Technical Guidelines for the Application of Biomarkers in Clinical Research and Development of Antineoplastic Drugs
Technical Guidelines for Clinical Evaluation of Intravenous Anesthetic (Consultation Draft)
Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Chemical Drugs Against Covid-19 (Trial)
Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-inflammatory Drugs for Covid-19 Pneumonia (Trial)
Technical Guidelines for Non-clinical Research on Neutralizing Antibody Drugs Against Covid-19 (Trial)
Technical Guidelines for Clinical Trials for Weight Control Drugs
Technical Guidelines for Clinical Trial Endpoints for Advanced Prostate Cancer (Consultation Draft)
Technical Guidelines for Pharmacological Research on Innovative Drugs
ICH M7 (R2) – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to imit Potential Carcinogenic Risk
(in consultation before being adopted in China)
Welcome to contact BaiPharm for details of any foregoing regulations. We offer a full portfolio of China NMPA compliance consulting services. BaiPharm professionals have successfully carried out a great number of market entry projects of finished drugs, APIs, excipients and packaging materials.