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WHO joins joint EMA, FDA and TGA inspection programme

By Gareth MacDonald+

07-Mar-2012

The joint US FDA and EMA active pharmaceutical ingredient (API) manufacturing facility inspection programme has signed up the World Health Organisation as a member. 

According to the European Medicines Agency (EMA) the World Health Organisation (WHO) has become a member of the scheme – which sees regulators sharing inspection duties and information on facilities they visit  - through its prequalification of medicines programme.

Prior to joining the WHO assessed the quality of pharmaceutical production based on data submitted by manufacturers and its own investigations.

EMA spokeswoman Vladimira Yalmanova told in-Pharmatechnologist.com the WHO’s involvement “will be the same as with the other participants, sharing of information and joint inspections when relevant. Sharing is possible when the WHO inspections are conducted by inspectors from Europe, US or Australia.

For the WHO its participation should be beneficial to the recently launched Prequalification of API programme. It allows also the existing programme designed for US/Europe/Australia to participate in the effort of WHO to facilitate access to quality medicines for the developing countries through prequalification of good-quality APIs which are vital to the production of good-quality medicines.

Yalmanova added that the WHO’s participation will allow the most efficient possible use of inspection resources - and therefore oversight - for the  increasingly globalised drug manufacturing industry.

The announcement follows two weeks after the US Food and Drug Administration (FDA) and the EMA published an updated set of guidelines for all parties involved in the inspection scheme .

In it the regulators explain that: “The overall objective is to foster greater international collaboration and information sharing to help to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication.”

The WHO joins the EMA, the FDA, the European Directorate of the Quality of Medicines and Healthcare (EDQM) and EU member states as a member the programme.

Australia’s Therapeutic Good Administration (TGA) – which took part in the pilot joint inspection scheme that operated between 2008 and 2010  – has also agreed to join the scheme, which is something that did not look likely when in-Pharmatechnologist.com spoke to the EMA in December last year .

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