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TOP-Pharma Editorial Team -
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 Pharmaceutical Inspection Co-operation Scheme (PIC/S). The decision was made at a PIC/S meeting in Istanbul...
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 NMPA Announcement No. 107, the revised regulation replaces the 2014 edition and introduces more comprehensive...
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 & Medicaid Services (CMS) plans to expand its Cell and Gene Therapy (CGT) Access Model beyond...

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