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252 changes

1d ago WHO News
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WHO Releases New Antibiotic Profiles for Drug-Resistant Infections

The World Health Organization (WHO) has released three new Target Product Profiles (TPPs) for antibacterial agents to address critical drug-resistant infections. These profiles guide the development of new antibiotics for multidrug-resistant Gram-negative infections, Gram-positive infections in vulnerable patients, and bacterial meningitis.

Priority review Guidance Pharmaceuticals
1d ago WHO News
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WHO Handbook Accelerates Hepatitis Elimination Action

The World Health Organization (WHO) has released a new implementation handbook to support countries in accelerating action towards hepatitis elimination by 2030. The handbook consolidates evidence-based recommendations and provides practical guidance for expanding prevention, testing, and treatment services.

Priority review Guidance Public Health
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Teva Octreotide Recalled Due to Manufacturing Deficiencies

Health Canada has issued a Type I drug recall for Teva Octreotide due to manufacturing site deficiencies identified at a foreign facility. These deficiencies could lead to potential quality issues, including compromised sterility and dosing accuracy. The recall is a precautionary measure.

Urgent Enforcement Pharmaceuticals
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Health Canada Health Product Safety Recap

Health Canada has issued its February 2026 Health Product InfoWatch, detailing recalls for Teva Octreotide due to GMP deficiencies and unauthorized health products. It also announces a consultation on controlling zuranolone under the Controlled Drugs and Substances Act.

Priority review Notice Pharmaceuticals
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Health Canada Health Product InfoWatch - February 2026

Health Canada's February 2026 Health Product InfoWatch includes a monthly recap of safety information, including a recall of Teva Octreotide and advisories on unauthorized products. It also announces a consultation on controlling zuranolone and new market authorizations with conditions.

Priority review Notice Pharmaceuticals
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Japan PMDA Drug Precaution Revisions for FY2025

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.

Priority review Guidance Pharmaceuticals
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PMDA Japan Drug Precaution Revisions

The PMDA Japan has updated drug precautions for several medications, including Andexanet alfa, Topiramate, and various VEGF/VEGFR inhibitors. These revisions reflect new safety information and investigation results, impacting the labeling and handling of these drugs.

Priority review Guidance Pharmaceuticals
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Raymond Chua's address at 29th Medical Device Regulators Forum

Raymond Chua's address at 29th Medical Device Regulators Forum

Routine Notice
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HSA Deepens International Partnerships for Biomedical Sector Growth

The Health Sciences Authority (HSA) of Singapore has announced deepened collaborations with Malaysia and Uzbekistan to facilitate access to medicines and medical devices. These partnerships include a formalised Medical Device Regulatory Reliance Programme with Malaysia and a Memorandum of Understanding with Uzbekistan for broader regulatory cooperation.

Routine Notice Healthcare
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Therapeutic Product Approvals and Indications List Update

The Health Sciences Authority (HSA) of Singapore has published updated lists of new therapeutic product approvals and new indications for registered therapeutic products, effective March 2026. These lists are intended for healthcare professionals and industry members.

Routine Notice Pharmaceuticals

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