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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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POLICY
China to Carry out National Insulin Procurement
China will pilot a nationwide insulin procurement which may refer to the previous pilot insulin procurement scheme in Wuhan. It means the price of insulin products will be significantly reduced, and the market share of relevant pharmaceutical companies in China will be affected.
Mar 08, 2021

REGULATION
China CDE to Disclose New Drugs' Technical Review Reports
China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Mar 08, 2021

INDUSTRY
In Light of the 14th Rare Disease Day, How Is China Doing on Rare Disease Drugs?
On February 28, 2021, the international community observes the 14th Rare Disease Day, which is a time of the year to raise awareness among the general public and to also reflect upon the progress of orphan drugs development.
Mar 08, 2021

POLICY
China Releases Draft List of Second Batch of Encouraged Generic Medicines
On Dec. 30, 2020, China National Health Commission issued the Draft List of Second Batch of 19 Generic Medicines, encouraging pharmaceutical firms to develop and produce them. Medicines for chronic obstructive pulmonary disease and asthma are included in the list.
Mar 08, 2021

POLICY
China's 2020 National Reimbursement Drug List Includes 119 Additional Drugs
China's National Healthcare Security Administration and the Ministry of Human Resources and Social Security have released the 2020 Edition of the National Reimbursement Drug List (NRDL) on Dec. 28, 2020, which will take effect on Mar. 1, 2021.
Mar 08, 2021

POLICY
China to Exempt Import Tariffs on 61 Active Pharmaceutical Ingredients for Anticancer and Rare Disease Drugs
China will apply interim import tax rates that are lower than most-favored-nation tariffs on 883 kinds of goods from Jan. 1, 2021, according to the 2021 Tariff Adjustment Plan issued by the Customs Tariff Commission of the State Council on Dec. 23, 2020.
Mar 08, 2021

POLICY
Chinese Market Becomes More Intense for Antidiabetic Drugs
China's fourth round of national centralized drug procurement has begun, according to the Jinfu Chen, deputy head of the National Healthcare Security Administration in Beijing on Jan. 29, 2021. This time five new diabetes medications are included in the procurement list. They are empagliflozin, canagliflozin, repaglinide, nateglinide, and gliclazide.
Mar 08, 2021

REGULATION
China Requires Drug Market Authorization Holders to Submit Annual Report
On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Mar 08, 2021

REGULATION