China Encourages Innovative Drug R&D in Draft of Regulations for Implementing DAL, 2022

On May 9, China National Medical Products Administration (NMPA) released the draft of the revised Regulations for Implementation of the Drug Administr…

Pharma
May. 20th, 2022

Generic Drug Application (ANDA) in China

Generic drugs comprise a significant part of China’s pharmaceutical market. In 2020, 63% of marketed drugs in China were generics. The Chinese g…

Pharma
May. 19th, 2022

China Pharmaceutical Regulatory Updates | March 2022

China NMPA Releases the 52nd List of RLDs On March 11, China NMPA released the 52nd List of Reference Listed Drugs (RLDs). The list covers 52 drugs, i…

Pharma
Apr. 08th, 2022

Drug Application Fees for FY 2022 in China and the U.S.

In general, drug regulators charge fees from applicants to ensure the review of drug applications proceed efficiently. For drug applicants, the fees a…

Pharma
Feb. 16th, 2022

Biogen’s Rare Disease Drug Gets Access to More Patients in China Due to NRDL

In December 2021, Biogen cut the price of Spinraza (Nusinersen Sodium Injection) from 700,000 yuan per dose to 33,000 yuan per dose. The move was for …

Pharma
Feb. 16th, 2022

China Greenlights Online Sales of Prescription Drugs in Shenzhen

China officially permits Shenzhen to pilot the online sales of prescription drugs, according to the market-access-relaxing measures released by Nation…

Pharma
Feb. 16th, 2022

New Market Entry Pathways of Medical Products: Special Medical Zones in China

In China, many patients resort to unconventional means of receiving treatment for their diseases, like going abroad or relying on surrogate shoppers. …

Pharma
Nov. 19th, 2021

China to Implement Good Pharmacovigilance Practices

China National Medical Products Administration (NMPA) officially issued the Good Pharmacovigilance Practices (GVP) on May 13, 2021, after releasing th…

Pharma
Nov. 19th, 2021

Expedited Programs for Drug Registration in China

According to China’s Administrative Measures for Drug Registration enacted since July 1, 2020, the National Medical Products Administration (NMP…

Pharma
Nov. 19th, 2021

China DMF Filing, Review & Approval System for APIs, Pharmaceutical Excipients & Packaging Materials

China’s drug review & approval system has undergone substantial reforms since it joined the ICH (International Council for Harmonisation of …

Pharma
Nov. 19th, 2021
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