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GROWING THE RESPONSIBLE USE OF MEDICINES

UNITING IN DISASTERS

Responsible use of medicines should run through all

our practices and in all situations, including disasters.

During Typhoon Haiyan in the Philippines, members

of the Military and Emergency Pharmacy Section

(MEPS) were able to use the FIP MEPS discussion site

to collaborate, liaise and problem solve. Significant

support was also relayed to our local Philippines

association for post-typhoon activities.

FACILITATING UNIVERSAL HEALTH COVERAGE

Getting medicines to patients at the right time can be helped by faster

approval processes. By February 2014, five new biowaiver monographs had

been published by the regulatory sciences special interest group s focus

group on the biopharmaceutics classification system (BCS) and biowaivers,

taking the list of monographs produced by this group to over 40.

The biowaiver procedure uses simple dissolution methods rather than

expensive and time-consuming pharmacokinetic studies in humans to

test for bioequivalence of drug products, thus reducing the time to gain

marketing authorisation.

BRIDGING GAPS

FIP co-sponsored an international symposium on bridging studies,

held in Taipei, China Taiwan, to work on their harmonisation. Why is

harmonisation important? Most medicines are currently developed for

exclusive use in one country, and there is a continuing debate on how

best to use clinical data obtained from global studies so as to avoid

duplicative testing, thus reducing delay in availability of medicines

and the cost of development. After the symposium, it was announced

that 12 countries had tentatively agreed to work together to speed up

launching new medicines in the Asia-Pacific region. read more

read more

VIGNETTES 2013/14