top-pharma

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Regulatory Affairs

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...
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Medical Devices

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...
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Biotech

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 &...
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Inspection Insights

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...
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Inspection Insights

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...
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Pharma

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...
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Inspection Insights

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...
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Advanced Therapies

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...
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Findings & Enforcement

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...
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Compliance

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...
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Explore more

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

top-pharma -

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

top-pharma -

FDA proposes framework for individualized gene therapies as CMS expands access

top-pharma -

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

top-pharma -

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

top-pharma -

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

top-pharma -

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

top-pharma -

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

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Baxter Warning Letter highlights systemic weaknesses in contamination control

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UK government confirms indefinite recognition of CE-marked medical devices

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Remote Russian GMP inspections: interpreter insights on preparation, documentation and conduct

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MHRA outlines AI and MedTech regulatory plans at AdvaMed 2026

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EMA opens consultations on confirmatory platform trials and pharmacovigilance data quality

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AI in drug development: ten principles for data integrity, validation and lifecycle oversight

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PIC/S updates qualification and validation guidance: PI 006-4 now in force

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FDA, Sanofi and Gilead discuss AI data readiness and risk-based validation

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EU veterinary GMP regulations take effect, requiring quality-system reviews

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European Commission grants €10 million to EMA to support the African Medicines Agency

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Sanofi agrees to acquire Inhibrx, adding rare disease candidate to its portfolio

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PlaqueTec and Babraham Institute partner on CAD blood study

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