IPEC e-newsletter - Excipients Insight March 2017 - 31-03-17

 

Inside this issue

     

EU and US will recognize each other's GMP inspections

Earlier this month, the US Food and Drug Administration (FDA) and the European Commission agreed to recognise each other's inspection assessments at pharmaceutical manufacturing facilities.

The Mutual Recognition Agreement – which was signed on 2 March – has been three years in development and amends a prior 1998 agreement on Good Manufacturing Practices (GMP) which was not fully implemented because of legal issues.

The new transatlantic agreement builds on collaborative measures such as the joint audit programme "will help to make better use of inspection capacity and reduce duplication," said the European Medicines Agency (EMA) in a statement.

The EU already has MRAs in place with other countries including Australia, Canada, Japan, Switzerland and New Zealand.

"Each year, national competent authorities from the EU and the US FDA inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with GMP," said the EMA. "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."

Many provisions of the agreement have already entered into force and others will enter into force on November 1, 2017. By that date, the EU will have completed its assessment of the FDA and the FDA is expected to have completed its assessment of at least eight EU Member States, and will be gradually expanded to all Member States. 

The MRA covers both medicinal products and APIs, but excludes human blood, plasma, tissues and organs, as well as veterinary immunologicals.

In a blog post on the MRA published towards the end of last year, the FDA said stressed Brexit will have "no impact on FDA’s relationship with our UK counterparts at this time." Once the UK finalizes its departure from the EU, FDA and the UK will re-examine existing commitments and, if necessary, renegotiate any existing agreements. 

 

 

 

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