WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
WHO Technical Report Series, No. 981 - World Health Organization
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<strong>WHO</strong> Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report<br />
impurities); and a question and answer (Q&A) document on Q7 (GMP for active<br />
pharmaceutical ingredients (APIs)).<br />
The Expert Committee expressed its thanks for the report.<br />
2.2.4 International Conference of Drug Regulatory Authorities<br />
The International Conference of Drug Regulatory Authorities (ICDRA) provides<br />
medicines regulatory authorities of <strong>WHO</strong> Member States with a forum to meet<br />
and discuss ways to strengthen collaboration. The ICDRAs have been instrumental<br />
in guiding regulatory authorities, <strong>WHO</strong> and interested stakeholders and in<br />
determining priorities for action in the national and international regulation of<br />
medicines, vaccines, biomedicines and herbals.<br />
The programme of the 15th ICDRA, scheduled for 23–26 October 2012<br />
in Tallinn, Estonia, was outlined for the Expert Committee. The Committee's<br />
attention was also drawn to a pre-conference meeting on “The quality of medicines<br />
in a globalized world: focus on active pharmaceutical ingredients” organized<br />
jointly by the State Agency of Medicines of Estonia, the European Directorate for<br />
the Quality of Medicines & <strong>Health</strong>Care (EDQM) and <strong>WHO</strong>.<br />
The Expert Committee noted the programme for both the conference<br />
and the pre-conference meeting.<br />
<strong>WHO</strong> <strong>Technical</strong> <strong>Report</strong> <strong>Series</strong>, <strong>No</strong>. <strong>981</strong>, 2013<br />
2.2.5 <strong>World</strong> <strong>Health</strong> Assembly resolution on new Member<br />
States' mechanism on substandard/spurious/falselylabelled/falsified/counterfeit<br />
medical products<br />
The Secretary to the Expert Committee described the creation of a new Member<br />
States' mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit<br />
(SSFFC) medical products. This mechanism was agreed upon at the Sixty-fifth<br />
<strong>World</strong> <strong>Health</strong> Assembly in 2012 following the recommendation of a working<br />
group of Member States on SSFFC medical products which met twice in 2011.<br />
The mechanism, which is set to meet at least once each year, is open to<br />
representation by all <strong>WHO</strong> Member States and, where applicable, by regional<br />
economic integration organizations. The goal of the mechanism is “to protect<br />
public health and promote access to affordable, safe, efficacious and quality<br />
medical products, promote, through effective collaboration among Member<br />
States and the Secretariat, the prevention and control of substandard/spurious/<br />
falsely-labelled/falsified/counterfeit medical products and associated activities”.<br />
The first meeting of this new mechanism would discuss the structure, governance<br />
and a work plan in <strong>No</strong>vember 2012 in Argentina.<br />
It was recognized that the Expert Committee might have a role in<br />
supporting the mechanism.<br />
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