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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.

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