Pharma & Drug Safety

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.

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.

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.

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.

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.

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

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

HSA Charges Man for Trafficking Etomidate Vaporiser Pods

The Health Sciences Authority (HSA) of Singapore has charged a 34-year-old man for allegedly trafficking etomidate vaporiser pods. The charges follow an enforcement operation where HSA seized over 900 tablets, cough syrup, and etomidate-containing vaporiser pods. Stricter penalties for etomidate trafficking are in effect.

HSA Achieves WHO ML4 Recognition for Medical Devices, Expands Biomedical Role

The Health Sciences Authority (HSA) in Singapore has achieved the highest World Health Organization (WHO) Maturity Level (ML4) for medical devices regulatory systems, becoming the first national authority globally to do so. HSA is also expanding its economic role to support the biomedical sector's growth.

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.

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.