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BioWorld - Friday, April 3, 2026
Home » Topics » Regulatory, BioWorld Asia

Regulatory, BioWorld Asia
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Eyepoint injector

China’s NMPA gives green light to Ocumension’s Yutiq intravitreal implant for uveitis

June 21, 2022
By Tamra Sami
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
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COVID-19 vaccine vials on conveyor belt

WTO’s COVID-19 IP waiver playing to rotten tomatoes

June 21, 2022
By Mari Serebrov
While the World Trade Organization (WTO) is taking a victory lap for getting a five-year intellectual property (IP) waiver across the finish line for COVID-19 vaccines, the accomplishment is being panned by spectators on both sides of the track.
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U.K. flag on stethoscope

MHRA goes big with harmonization with IMDRF, ICH

June 21, 2022
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches.
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Shipping container with flag of China

China to ramp up volume-based procurement policies for drugs and devices to control prices

June 21, 2022
By Tamra Sami
China will continue to ramp up volume-based procurement (VBP) policies that bring down drug and device prices for public hospitals with volume. Governmental agencies at the local and national levels coordinate drug prices via government-organized procurement programs that include VBP and pricing negotiations for inclusion on the National Reimbursable Drug List.
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Syringe and COVID-19 vaccine vials as question mark

COVID-19 IP waiver on the line at WTO conference

June 14, 2022
By Mari Serebrov
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
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China in red on globe

Everest wins first approval in China for breast cancer drug Trodelvy

June 14, 2022
By Doris Yu
Everest Medicines Ltd. has picked up its first marketing approval in China for Trodelvy (sacituzumab govitecan), a medicine licensed from Gilead Sciences Inc. It was approved to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
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Investigation into questionable investments prompts executive re-shuffle at China’s Cstone

June 7, 2022
By Tamra Sami
Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
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Chinese flag on flagpole

GSK’S 2-dose HPV vaccine gains expanded approval in China

May 31, 2022
By Doris Yu
China has granted a green light for Glaxosmithkline plc’s human papillomavirus (HPV) vaccine, Cervarix, for girls ages 9 to 14. The HPV bivalent vaccine is used against types 16 and 18 in a two-dose course to prevent cervical cancer. It’s the first imported two-dose HPV vaccine for the age group to be approved in China, the company said. A three-dose schedule of Cervarix won Chinese approval in July 2016 for girls and women ages 9 to 25. To date, the two-dose regimen has been approved in about 100 global markets.
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Gavel and block with Chinese flag

China proposes new regulations for drug administration law

May 31, 2022
By Tamra Sami
China’s National Medical Products Administration (NMPA) released a new draft amendment to its Drug Administration Law (DAL) that introduces some important changes to the regulatory framework and is aimed at codifying initiatives implemented in the current DAL, such as patent linkage and regulatory data protection.
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U.S., China wrecking balls

Clock is ticking on China-based securities on US exchanges

May 31, 2022
By Mari Serebrov
About $1.7 trillion in securities of China-based issuers listed on U.S. exchanges could face trading prohibitions in as little as two years, Y.J. Fischer, director of the U.S. SEC’s Office of International Affairs, warned during remarks at the May 24 annual meeting of the International Council of Securities Associations.
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