The page does not exist.

Back to Homepage ⟶

― Or explore...

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...
TOP-Pharma Editorial Team -
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...
TOP-Pharma Editorial Team -
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 &...
TOP-Pharma Editorial Team -
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...
TOP-Pharma Editorial Team -
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...
TOP-Pharma Editorial Team -
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...
TOP-Pharma Editorial Team -
Load more