licensing system and the assessment of quality defects of API and medicinal products) including an on-site assessment visit carried out by a delegation of PIC/S from 25 November to 1 December 2006. A follow-up report on outstanding issues was presented at the Singapore meeting. MMA applied on 2 October 2006 and has been assessed based on assessment reports from Canada and the European Union which both evaluated Malta in the framework of their MRA.
The Committee reviewed the progress made in the assessment of applications submitted by France’s Agency for Veterinary Medicinal Products, Israel’s Ministry of Health, Lithuania’s Department of Pharmacy, the Thai FDA and the US FDA. On-site assessment visits to France, Israel and Thailand are scheduled to take place in 2008.
The Committee also noted that Cyprus’ Pharmaceutical Services had applied for PIC/S membership on 2 November 2007 and nominated a Rapporteur and a Co-Rapporteur. The competent authorities of Indonesia and New Zealand also announced their intention to apply for PIC/S membership by 2008. The Committee was informed that the merger between Australia’s TGA and New Zealand’s MedSafe had been put on hold.
The Committee reviewed the reassessment of Switzerland’s Agency for Therapeutic Products (Swissmedic) and Liechtenstein’s “Kontrollstelle für Arzneimittel” (KA). Since Swissmedic met all PIC/S requirements, the Committee decided that the reassessment could be closed. Due to the reorganisation of the “Kontrollstelle für Arzneimittel” (KA), now “Amt Für Gesundheit” (AG), Liechtenstein was invited to make a follow-up at the next meeting. The Committee took note that the reassessment of Austria’s Medicines and Medical Devices Agency (AGES PharmMed) had started.
The Committee discussed future audits of GMP inspectorates. It decided to develop a roster to enable a better sharing of duties among PIC/S Participating Authorities. The Committee also discussed different possibilities to cover auditors’ expenses to allow Participating Authorities with limited resources to take part in audits.
Training for inspectors
The Committee reviewed the programme of the 2008 Seminar which would be held in Krakow (Poland) on Good Distribution Practices for both API and medicinal products. It also noted that the 2009 Seminar would be organised in Uppsala (Sweden) on Sterile Aseptic Manufacturing for both API & medicinal products and that the 2010 Seminar on Herbal Medicines would be hosted by Malaysia.
The Committee also reviewed the outcome of last meetings organised by PIC/S Expert Circles:
Expert Circle on Hospital Pharmacy (Oslo, Norway, 25-27 June 2007);
Expert Circle on Quality Risk Management (Paris, France, 2-3 July 2007);
Expert Circle on Active Pharmaceutical Ingredients (Drafting Group meeting, Paris,
France, 12-14 September 2007);
Expert Circle on Computerised Systems (Dublin, Ireland, 1-3 October 2007);
Expert Circle on Human Blood and Tissue (Dublin, Ireland, 1-5 October 2007).
The Committee decided to review the composition of Steering Committees of Expert Circles and invited three Expert Circles to review their mandate.