From 8 to 10 April 2019, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The headlines from the meeting were:
- PIC/S Inspection Reliance Initiative: successful examples of desk-top assessments in support to PIC/S GMP Inspection Reliance Guidance
- updates on future revisions to PIC/S GMP Guide: Annexes 1 (sterile), 2 (biologicals and advanced therapy medicinal product [ATMP]), 13 (investigational medicinal product [IMP]) and 16 (certification by an authorised person [AP] and batch release)
- new working group established to develop a PIC/S Aide Memoire on Tissues and Cellular Therapy Products Inspections (excluding ATMP)
- progress in amendment of Pharmaceutical Inspection Convention (PIC) Scheme
- PIC/S 2019 Seminar to be hosted by Japan/Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) in Toyama and updates on PIC/S Inspectorates’ Academy and future training activities
- completion of pre-accession of Saudi Arabia/Saudi Food and Drug Authority (SFDA) and new PIC/S pre-accession application received from Bangladesh/Directorate General of Drug Administration (DGDA)
- bilateral meetings with China/National Medical Products Administration (NMPA) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
The full press release is available on the PIC/S website.
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