LONDON, Mar 2 (APM) - Drug regulators in Europe and the U.S. will recognise inspections of manufacturing sites conducted in each other's respective region as part of a new agreement signed on Thursday.
The mutual recognition agreement will see the U.S. Food and Drug Administration rely on inspections by national competent authorities in each EU country, co-ordinated by the European Medicines Agency, while the EMA will rely on inspections in the U.S. by the FDA.
In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be limited to "exceptional circumstances", said the EMA in a statement.
The EMA said the agreement is underpinned by "robust evidence" on both sides of the Atlantic that the two regions have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.
The regulator added that it will enable both bodies to make "better use of their inspection resources" to help them to focus on other parts of the world where active pharmaceutical ingredients and medicines for the EU or U.S. markets are manufactured. This includes India where there have been a number of high profile cases of factories failing to meet good manufacturing practice standards in recent year.
The EMA and FDA have been working on developing a close working relationship for several years, launching an international collaboration on good manufacturing practice (GMP) inspections in 2011 (APMMA 26714).
The following year the two bodies launched an initiative to share work on inspections of manufacturing sites in each other's territories in January 2012 - a process that has led to Thursday's agreement.
Many provisions of the agreement have already entered into force, said the EMA, and others will come into force on November 1, 2017. By that date, the EU is expected to have completed its assessment of the FDA and the FDA is expected to have completed its assessment of at least eight EU countries, and will be gradually expanded to the remaining countries.
The news will be welcomed by many in the industry, including U.S. generics trade body the Generic Pharmaceutical Association (GPhA), which has advocated for closer collaboration between the EMA and FDA.
The organisation's vice president for regulatory sciences David Gaugh told a conference in January this year that a more joined-up regulatory approach is necessary considering the global nature of the pharma industry and that greater collaboration can lead to a reduction in duplication (APMMA 51540).
He added that the FDA intends to expand the scope of GMP mutual recognition to other highly regulated markets.
This could include Japan, whose pharma regulatory agency PMDA joined the international collaboration on GMP inspections in 2016 (APMMA 50613).
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