2009-2010 - AESGP
2009-2010 - AESGP
2009-2010 - AESGP
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A n n u a l R e p o r t 2 0 0 9 - 2 0 1 0<br />
4<br />
“... Promotion of effective self-care is important not only to reduce health-care costs,<br />
but it can also lead to improvement of equity in health.”<br />
in which the self-care sector finds itself,<br />
and recommended careful consideration<br />
of the data that should,<br />
or should not, be released to the<br />
public….including competitors.<br />
In a note to the Heads of Medicines<br />
Agencies dated March <strong>2009</strong>, the<br />
European Commission made it clear<br />
that centrally authorised medicines<br />
would have to be switched using<br />
the central route, and the first central<br />
switches of orlistat and pantoprazole<br />
in January and June <strong>2009</strong>, respectively,<br />
marked a major milestone in<br />
the history of the self-care sector.<br />
It may be expected that several innovative<br />
switch applications will<br />
be reviewed by the Committee for<br />
Medicinal Products for Human Use<br />
(CHMP) in the near future, allowing<br />
the products concerned to become<br />
pan-European. The constructive discussions<br />
between the Agency and<br />
<strong>AESGP</strong> during the regular platform<br />
meetings are therefore fundamental<br />
to creating mutual understanding<br />
and to ensuring a constructive way<br />
forward. Through direct interaction<br />
with a CHMP sub-group at the next<br />
platform meeting, the Committee is<br />
expected to share the lessons learnt<br />
from the first two central switches.<br />
<strong>AESGP</strong> is eagerly looking forward<br />
to the CHMP’s vision for the future.<br />
Turning towards the decentralised<br />
and mutual recognition procedures,<br />
<strong>AESGP</strong> is equally keen to ensure<br />
that these procedures work well. A<br />
performance tracking survey carried<br />
s<br />
out through the <strong>AESGP</strong> membership in<br />
the second half of <strong>2009</strong> provided an<br />
objective picture of the situation. Although<br />
a number of improvements and<br />
efforts could be noted, some delays and<br />
backlogs still needed to be resolved.<br />
The results were presented to a panel of<br />
CMD(h) members at the <strong>AESGP</strong> conference<br />
in January and led to an enriching<br />
and open debate which, at the request of<br />
some authorities, may be followed up by<br />
meetings at the national level to discuss<br />
the country-specific findings.<br />
ICH<br />
<strong>AESGP</strong> continued to coordinate the International<br />
Conference on Harmonisation<br />
(ICH) activities on behalf of the World<br />
Self-Medication Industry (WSMI) of<br />
which it is a founding member. Experts<br />
participated in the June ICH meetings in<br />
Yokohama, Japan and in St Louis, USA,<br />
in October.<br />
Source: WHO Report of the Regional Consultation: Self-care<br />
in the Context of Primary Health Care, January <strong>2009</strong>.<br />
DAILY REGULATORY AND<br />
SCIENTIFIC WORK<br />
On top of its political activities, <strong>AESGP</strong><br />
continued to provide its membership with<br />
a continuous flow of information and opportunities<br />
to take part in consultations<br />
and meetings. On the issue of quality/<br />
GMP, <strong>AESGP</strong> participated in the yearly<br />
joint EMA Quality Working Party/Interested<br />
Parties meeting and in a workshop<br />
on variations sponsored by both the<br />
Agency and the Co-ordination Group<br />
for the Mutual Recognition and Decentralised<br />
Procedures – Human (CMD(h)).<br />
The association presented the results of its<br />
membership survey on the issue of atypical<br />
actives to the Good Manufacturing<br />
Practices/Good Distribution Practices Inspectors<br />
Working Group, and pledged<br />
it would continue to monitor the issue.<br />
<strong>AESGP</strong> also discussed early experience<br />
with the PSUR work-sharing group at its<br />
meeting in September and participated<br />
in the CMD(h) paediatric subgroup in the<br />
same month. <strong>AESGP</strong> also played an active<br />
role in the Commission’s workshop<br />
to prepare a written consultation on the<br />
Clinical Trials Directive and attended<br />
an Agency meeting on Good Clinical<br />
Practices. Over the past 12 months the<br />
association contributed to consultations<br />
on a wide variety of topics with over<br />
30 position papers and response documents<br />
and responded in a timely manner<br />
to the many scientific and/or regulatory<br />
requests from its members.