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 Hazchem Registration Online System to be Implemented Nationwide in 2022

On January 5, 2022, the Work Safety Committee of the State Council issued the National Plan for Centralized Management of Safety Risks of Hazardous Ch…

Chemical
Jan. 17th, 2022

FDA Withdraws Temporary Guidance for Hand Sanitizers

Companies may no longer manufacture under Temporary Guidance beyond December 31, 2021 The Temporary Emergency Use Authorization (EUA) on hand sanitize…

Biocide
Dec. 23rd, 2021

China Enacts Mandatory Standard for Body-use Antimicrobial Lotions(GB 384056-2020)

On December 1, 2021, China began to enact the national standard, “GB 38456-2020 Hygienic Requirements for Antibacterial and Bacteriostatic Lotion”. Th…

Biocide
Dec. 17th, 2021

China MoARA Requires More Image Data Supporting Fertilizer Registration

On October 21st and 22nd 2021, the Chinese Ministry of Agricultural and Rural Affairs concluded the 6th session of the 9th Review Committee of Fertili…

fertilizer
Dec. 17th, 2021

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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