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― Or explore...

Kazakhstan to undergo PIC/S on-site assessment in 2027

Kazakhstan has been approved for an on-site assessment mission and an observed inspection in 2027 as part of its application for membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The decision was made at a PIC/S meeting in Istanbul...
TOP-Pharma Editorial Team -

China’s revised medical device GMP takes effect, strengthening quality and contract manufacturing requirements

China’s National Medical Products Administration (NMPA) put its revised Good Manufacturing Practice (GMP) for Medical Devices into effect on 1 November 2026. Issued under NMPA Announcement No. 107, the revised regulation replaces the 2014 edition and introduces more comprehensive...
TOP-Pharma Editorial Team -

FDA proposes framework for individualized gene therapies as CMS expands access

The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare & Medicaid Services (CMS) plans to expand its Cell and Gene Therapy (CGT) Access Model beyond...
TOP-Pharma Editorial Team -

Clopidogrel oral liquids recall: assay control, OOS investigation and batch impact assessment

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall covering all strengths and all batches of Xeal Pharma’s clopidogrel oral solutions and suspensions manufactured before the recall notification. A formulation error resulted in...
TOP-Pharma Editorial Team -

FDA inspections: who will inspect your site — and who decides the outcome?

An FDA inspection involves more than the investigators who visit a manufacturing site. The reason for the inspection, the field team's findings and the agency's final classification are separate elements of a regulatory process. Understanding how these responsibilities are...
TOP-Pharma Editorial Team -

UK announces AI Biosecurity Lab with up to £300 million in public and industry support

The UK government has announced the establishment of the AI Biosecurity Lab (AIBL), a dedicated organisation intended to use advanced artificial intelligence (AI) to strengthen the detection and response to biological threats. The lab is backed by £100 million...
TOP-Pharma Editorial Team -

Who will inspect your pharmaceutical site? A guide to the global GMP inspection landscape

Inspection responsibilities depend on a manufacturing site's location, activities, target markets and applicable regulatory procedures — not simply on the name of a medicines agency. Understanding these factors helps manufacturers identify which authorities may inspect their facilities and how...
TOP-Pharma Editorial Team -

Council of Europe proposes regulatory framework for human organs manipulated ex situ

The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality of Medicines & HealthCare (EDQM), has published a position paper entitled “The regulatory approach to...
TOP-Pharma Editorial Team -

Baxter Warning Letter highlights systemic weaknesses in contamination control

A September 2026 FDA Warning Letter to Baxter International identifies deficiencies in cross-contamination prevention, aseptic processing, environmental monitoring and quality investigations. The findings highlight why a documented Contamination Control Strategy (CCS) must be supported by evidence that manufacturing processes...
TOP-Pharma Editorial Team -

UK government confirms indefinite recognition of CE-marked medical devices

The UK Government has confirmed that Great Britain intends to recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) certified under the EU Medical Devices Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (EU...
TOP-Pharma Editorial Team -
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