Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) has now offered New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) as well as Chinese Taipei/ Taiwan Food and Drug Administration (TFDA) to join the Scheme from January 1, 2013. Medsafe will become PIC/S’ 42nd Participating Authority and TFDA its 43rd Participating Authority.
Medsafe applied for membership in April 2010. A documentation assessment was conducted in view of its accession to PIC/S, followed by an on-site visit in February 2012. The Audit team recommended to the Committee to accept the membership application of Medsafe.
TFDA applied for membership back in June 2010 and is competent for modern medicines. A documentation assessment was conducted in view of its accession to PIC/S, followed by an on-site visit on June 4-8, 2012. The Audit team recommended to the Committee to accept the membership application of TFDA.
Both delegations welcomed their accession by thanking PIC/S and the Audit teams for the help and support provided. The PIC/S Chairperson congratulated both Medsafe and TFDA on their new status.
Further to the submission on July 16, 2012 of a pre-accession application request by Uganda’s National Drug Authority (NDA), Members nominated the Rapporteur and Co-Rapporteurs in charge of pre-assessment.
Further, the PIC/S Committee reached an important step for evaluation and re-evaluation of PIC/S Participating Authorities and future new Applicant Authorities by formally adopting the Revised PIC/S Audit Checklist in connection with the PIC/S Assessment & Joint Reassessment Programme. The document has been revised and updated, is set to come into force on January 1, 2013. The Audit Report template was successfully revised and is presently available. This report must be used to document any audit conducted within the assessment of new Applicant Authorities; and the Joint Reassessment Programme. It aims at defining how the audit report should provide a documented evidence of the audit process which has to be filled out by the audit team until completion of the audit.
The Committee reviewed the most recent replies received from Heads of Agencies from PIC/S Participating Authorities in connection with the survey carried out earlier this year on PIC/S new projects. The Working Groups established at the last Committee Meeting on May 7-8, 2012 in Geneva (Switzerland) to ensure the successful development of these projects reported the following progress.
With regards to the project of extending PIC/S’ mandate to new activities such as Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP), discussions were carried out with the EMA Ad Hoc Working Groups on GCP and pharmacovigilance.