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Home » Topics » Regulatory » Trade

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ABPI: UK’s rebate rates ‘send a terrible message’ to global investors

June 11, 2025
By Nuala Moran
No Comments
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
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Shipping container with flag of China

European Commission clamps down on Chinese med tech

June 10, 2025
By Mark McCarty
The trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 10, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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3D illustration of phage infecting bacteria

MHRA offers clarity for bacteriophage development, licensing

June 9, 2025
By Nuala Moran
No Comments
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first official guidance on how to develop bacteriophages as licensed medicinal products. This covers personalized phage therapies designed for specific patients – at present the only form in which they are available – but also is relevant to the development of off-the-shelf products for treating common infections.
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Pregnant woman

EMA: New clinical guideline includes pregnant, breastfeeding patients

June 5, 2025
By Nuala Moran
No Comments
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 4, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
Read More

US trade court blocks emergency tariffs, but threat remains

May 29, 2025
By Mari Serebrov
No Comments
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
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USTR begins search for biopharma R&D ‘freeloaders’

May 28, 2025
No Comments
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D.
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Trump tariff EO signing

South Korea urges US to exempt pharma, allies from tariffs

May 13, 2025
By Marian (YoonJee) Chu
No Comments
South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea Biotechnology Industry Organization on May 6 submitted comments to the U.S. Department of Commerce in response to its ongoing investigation of pharmaceutical imports.
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Jorge A. Goldstein at Bio Korea 2025
Bio Korea 2025

US legal issues to track in pharma, biotech

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
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