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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | May 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 82nd RLD List, 2. China CDE Releases Dossier Requirements for Imported Chemical Drugs’ Transfer to Domestic Production, 3. China CDR Consults on Principles for Determining the Scope of Indications for OTC Drugs, 4. China NMPA Consults on Requirements for Re-Registration Applications of Domestically Manufactured Drugs...
Jun 11, 2024
REGULATION
China Implements Procedures for Inclusion of Drugs in National Reimbursement Drug List (NRDL)
On May 31, 2024, China's National Healthcare Security Administration (NHSA) announced the issuance and implementation of the Procedures for Determining the Inclusion of Drugs in the National Reimbursement Drug List (Trial).
May 31, 2024
INDUSTRY
China Unveils Data on New Drug Clinical Trial Developments in 2023
China’s Center for Drug Evaluation (CDE) has released its 2023 Annual Report on the Development of New Drug Clinical Trials. The report provided a summary and analysis of the overall landscape of clinical trials, including the total number and basic characteristics of the trials.
May 27, 2024
REGULATION
China Changes Controls on Certain Drugs Including Dextromethorphan
On May 21, 2024, China NMPA and NHC further clarified that starting July 1, 2024, the research, procurement, mailing, transportation, import and export of the affected ingredients and drugs must be subject to the Drug Administration Law and Regulations on the Administration of Narcotic Drugs and Psychotropic Substances.
May 24, 2024
REGULATION
China Consults on Guidelines for Switching Prescription Drugs to OTC Status
On May 20, 2024, China's Center for Drug Reevaluation under the NMPA released the draft Guidelines on the Scope of Applications for Switching Prescription Drugs to Over-the-Counter (OTC) Drugs for public consultation. The draft outlines the key criteria and exclusions for such drug switching.
May 23, 2024
INDUSTRY
Drug Sales in China: Public Healthcare Institutions and Retail Pharmacies Generate 1,886.5 Billion Yuan in 2023
In 2023, the combined drug sales of public healthcare institutions and retail pharmacies in China totaled 1,886.5 billion yuan, representing a 5.2% increase compared to the previous year. Notably, public healthcare institutions accounted for 70.7% of the overall sales, with retail pharmacies contributing to the remaining 29.3%.
May 17, 2024
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2024
Check out the latest pharma regulatory updates in China: 1. China NMPA Adopts Electronic Documentation for Administrative Licensing in Drug Registration, 2. China NMPA Rolls out the 79th RLD List, 3. China Enhances Supervision and Management of Drug Operations, 4. China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China...
May 13, 2024
