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EMA and FDA to conduct joint pharma manufacturing inspections

Initiative will allow regulators to shift resources to other regions

US and European regulators will start sharing manufacturing inspections from next year in a move that is expected to allow them to shift resources to other regions.

At present the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) carry out a large number of inspections in each other's home territory, often duplicating the other's work.

The globalisation of pharmaceutical manufacturing is also a key driver, as many companies shift their bases away from Europe and the US to countries like China. Just last week AstraZeneca unveiled plans for a $200m manufacturing investment in China Medical City, Taizhou, Jiangsu province.

From January the scheme will see manufacturing site inspections shared, which the regulators said would free up their resources and reduce the burden on pharmaceutical manufacturers.

It will apply to inspections of manufacturing sites of human or veterinary medicines in the European Economic Area or the US, focusing on sites with a history of compliance with good manufacturing practice (GMP) and that are already known to the regulators.

The EMA said the changes would most likely affect routine post authorisation/surveillance inspections, with pre-authorisation/pre-approval inspections expected to continue largely unchanged.

The initiative will be reviewed after three years and follows two pilot projects run by the EMA and FDA that aimed to enhance global drug quality and safety by sharing inspection information.

The first, an 18-month Good Clinical Practice (GCP) initiative, saw the EMA and the FDA exchange more than 250 documents relating to 54 different medicines. Working with the GCP inspectors of the EU Member States they also organised 13 collaborative inspections of clinical trials.

The second project covered joint active pharmaceutical ingredients (API) inspections.

In addition to the EMA and FDA it also involved officials from France, Germany, Ireland, Italy, United Kingdom, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and Australia's Therapeutic Goods Administration (TGA).

The two-year pilot saw participants share their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and nine joint inspections.

The EMA said considerable amounts of information was exchanged in both pilots and that this not only increased understanding between the agencies but also highlighted a number of inspections that would be of value to more than one authority.

13th December 2011

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