Latest Regulatory Updates

Health Canada has issued a recall for Mint Pharmaceuticals' Mint-Losartan/HCTZ product due to concerns regarding the potential presence of nitrosamine impurities, posing a cardiovascular safety risk to patients.

Health Canada has issued a recall for REVOLUTION CT, a computed tomography (CT) system, due to a software defect that may result in inaccurate dose calculations and potentially expose patients to excessive radiation.

Health Canada has issued a recall for Baxter's Transseptal Needle Sets due to a quality defect that may compromise the integrity of the needle and potentially cause patient injury.

Health Canada has issued a recall for Paradigm Insulin Infusion pumps Remote programmers due to a potential software defect that could affect insulin delivery.

Health Canada has issued a recall for the PRISMAX Control Unit manufactured by Baxter due to a potential quality defect that may affect its performance and patient safety.

Health Canada has issued a recall for Baciject (Bacitracin for Injection USP) 50,000 units per vial due to a quality defect affecting sterility.

This publication commemorates the 30th anniversary of the International Council for Harmonisation (ICH) and highlights its role as a global platform for harmonizing technical requirements for pharmaceutical product registration.

Health Canada has issued a recall for the MiniMed 600 series insulin pumps due to a potential software bug that could cause incorrect insulin delivery, posing a risk to patients.

Health Canada has issued a recall for the S.M.A.R.T. FLEX Biliary Stent System due to a potential risk of device malfunction and patient injury related to a quality defect.

The ICH E6(R3) EWG published a report and video presentation summarizing progress on revisions to the guideline on Good Clinical Practice, focusing on areas like risk-based approaches, decentralized clinical trials, and patient engagement.

Health Canada has issued a recall for Ombrelle products due to a potential risk of bacterial contamination, advising consumers and healthcare professionals to discontinue use and follow specific instructions regarding product return.

Health Canada has issued a recall for Pharmascience PMS-Losartan product due to the presence of N-Nitrosodimethylamine (NDMA) above acceptable limits, potentially posing a health risk to patients.

Health Canada has issued a recall for Sivem Pharmaceuticals Losartan HCT product due to the presence of N-Nitrosodimethylamine (NDMA), a potential carcinogen, exceeding acceptable limits.

Health Canada has issued a recall for specific lots of Losartan tablets manufactured by Auro Pharma Inc. due to the presence of N-Nitrosodimethylamine (NDMA), a potentially carcinogenic substance, exceeding acceptable limits.

Health Canada has issued a recall for Riva-Risperidone tablets due to a quality defect affecting the stability of the product, potentially impacting patient safety.

Health Canada has issued a recall for Novo-Gesic Forte (naproxen sodium and esmolol hydrochloride) due to a quality defect affecting the stability of the product.

The ICH E8(R1) guideline on statistical principles for clinical trials has reached Step 4 of the ICH process, indicating its near completion and potential adoption by regulatory authorities worldwide.

The ICH M7(R2) draft guideline and addendum on impurities in new drug substances has reached Step 2 of the ICH process, indicating that it is now open for public consultation and review by regulatory authorities and stakeholder groups.

Health Canada has issued a recall for Advil Cold & Sinus Convenience Pack due to a quality defect affecting the presence of naproxen sodium.

The International Council for Harmonisation (ICH) has published a report detailing the findings of its 2021 implementation survey, assessing adherence to ICH guidelines by regulatory authorities and pharmaceutical companies globally.