WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
WHO Technical Report Series, No. 981, 2013
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responds to the fact that the problem of SSFFC medicines has continued to grow
in complexity, scale and geographical extent.
The project's long-term objective is to significantly improve the quantity,
quality and analysis of data on the incidence of SSFFC medicines – through
building on existing systems and by creation of a global surveillance and
monitoring system – to provide stakeholders with a sound basis on which to
build and collaborate on strategies for radically reducing the incidence of SSFFC
medicines and protecting supply chains.
Moreover, the increased quality of data and detailed information will
enable more efficient information exchange between countries and facilitate
regulatory action to protect patients and consumers.
The project aims to create a sustainable surveillance and monitoring
system for collecting, disseminating and analysing information on SSFFC
medicines, based upon analysis of experience with existing systems such as the
rapid alert system (RAS) in the WHO Western Pacific Region, and reflecting at
least the requirements of the project participants, but ideally the requirements
of all stakeholders. It will collect best practices for reporting of cases of SSFFC
medicines, and will facilitate common understanding and unification of the
minimum standards needed for individual case-reports. In addition it is intended
to help national medicines regulatory authorities (NMRAs) to identify SSFFC
medicines that have entered or that threaten to enter their country's supply
chain. Data and case-reports relating to SSFFC medicines will be collected from
NMRAs, to generate sound and reliable evidence of where incidence of such
medicines is most serious. The aim is to promote sharing of information and
expertise between NMRAs, in order to stimulate action (including alerts and
regulatory action to protect patients and consumers), and closer collaboration, to
minimize the negative impact of SSFFC medicines.
The project is currently in the pilot phase testing a new information
technology (IT) platform and reporting processes developed over the past two
years. At present 10 countries are participating actively in the pilot study. Once
the system is up and running other countries will be able to join.
The Expert Committee valued the new project on market surveillance
and noted the report.
8.4 Proposal for revision of good trade and distribution practices
The WHO guide on Good trade and distribution practices for pharmaceutical
starting materials was published in 2003. In 2006, the International Pharmaceutical
Excipients Council (IPEC) – an industry association comprising excipient
manufacturers, excipient distributors and their pharmaceutical customers –
published its GDP Guide for pharmaceutical excipients, which was fully aligned
with the WHO document. Since the publication of these guidelines, a number of