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Indonesian drug regulator to join PIC/S from 1 July

This article was originally published in SRA

Executive Summary

The Indonesian National Agency of Drug and Food Control is to join the Pharmaceutical Inspection Convention and Co-operation Scheme on 1 July, becoming the 41st regulatory authority to participate in the scheme1,2.

The PIC/S committee accepted the NA-DFC's membership application – submitted in April 2008 – at its latest meeting, in Geneva on 7-8 May. Before accepting the application, a PIC/S audit team assessed whether the Indonesian agency met all the necessary requirements to accede to the scheme; it suggested some actions and corrective actions which it says were duly undertaken by the NA-DFC.

The Japanese and South Korean drug regulatory authorities recently applied to join PIC/S3 and, at the Geneva meeting, the PIC/S committee appointed rapporteurs and co-rapporteurs to assess the applications.

New organisational structure and work projects



Also at the Geneva meeting, a new organisational structure was adopted for PIC/S that will become operational on1 January 2014.

The new structure aims to ensure a more participative and efficient organisation of PIC/S, where each sub-committee will be responsible for its respective core areas and will take the lead in developing policies. This new structure will include sub-committees in the fields of: training; expert circles; strategic development; (re-)assessment; GM(D)P harmonisation; risk, audit and budget; and communication.

In addition, the PIC/S committee established new working groups that would look at ways to: extend the PIC/S' mandate to new activities, such as Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPP); and create a PIC/S "inspectorate academy" to provide cost-efficient, primarily web-based, high quality harmonised training for inspectorates.

A new consultation procedure was also adopted between PIC/S and the European Medicines Agency to ensure better harmonisation between the European and PIC/S good manufacturing practice guides and related documents. This new consultation procedure will allow concerned parties to be informed of ongoing revisions of current documents and of the endorsement of new documents, including the sharing of early drafts in order to facilitate appropriate involvement in the adoption process.

The next meeting of the PIC/s committee will take place in Kiev (Ukraine) on 1-2 October.

References

1. PIC/S news, 22 May 2012, www.picscheme.org/news.php#n36

2. PICS press release, 21 May 2012, www.picscheme.org/bo/commun/upload/document/press-release-geneva-2012.pdf

3. South Korea and Japan apply for PIC/S membership; aide-memoire on quality risk management adopted, Scrip Regulatory Affairs, 26 April 2012

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