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EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase

Today, 1st November 2017, the EU-FDA mutual recognition agreement (MRA) of GMP inspections of human manufacturers will start coming into force. The initial phase of the agreement starts with recognition of the FDA and the first 8 EU member states, with other EU member states being added as their evaluation is completed by the US; until all agencies, have been assessed and recognised, on a rolling basis, by 15th July 2019.

This agreement marks a key milestone in the journey that started in 1998 with partial operation of the agreement which included important control elements such as the rapid alert system and where the only EU authority to be audited by FDA during this work was MCA, MHRA’s precursor.

Who are the initial 8 members states?

The 8 EU member states being recognised by the US Food and Drug Administration (FDA) as of 1st November are:

MHRA playing its part

Logo for the Medicines and Healthcare Regulatory AgencyIn 2014 negotiations re-started and MHRA participated in the discussions and meetings with FDA.  In 2015 MHRA agreed to lead the EU audit team which assessed the FDA, this audit built on work already in place such as the audit by PIC/S for FDA’s accession and also the EU assessment for listing to import APIs. The team, as part of its assessment, visited FDA's headquarters at White Oak in Maryland along with three district offices (Detroit, Kansas City and Philadelphia) and a FDA laboratory.

The audit team was led by Mark Birse and included Ian Rees from MHRA (UK), Guillaume Renaud from ANSM, (France), Marcin Rynkiewicz from GIF (Poland) and Ana Boban from HALMED (Croatia), Ana is now an inspector with MHRA.

FDA assessments of EU Authorities

Factors involved in compliance including laws, regulations, control, standards policy

The FDA’s assessment of EU member state authorities is predominately based on observing the audits conducted by EU GMP authorities on the other authorities – known as the Joint Audit Programme (JAP) and which is equivalent to the PIC/S audit system called the Joint Reassessment Programme (JRP).  Details about the on site assessment of MHRA are the subject of an previous post to this blog.

JAP belongs to the Heads of Medicines Agencies (HMA) and is run on their behalf by the Compliance Group.  The Group is part of the GMDP Inspectors Working Group of the EMA where secretarial support is by EMA staff, and MHRA involvement continues with the chair of the Group since 2012 being Ian Rees.  The Group has been managing a demanding programme in order to meet the challenging reporting deadlines set out in the mutual recognition agreement, so that FDA could assess the initial EU authorities in time for the 1st November 2017 start and then onwards to the 15th July 2019 completion date.

Further MHRA involvement has included the provision of ten auditors to the programme, 6 times leading their audit and 4 times being in an audit team, this was a significant resource contribution to the programme.

Individuals shaking hands with US and EU flags behindBenefits of the MRA

This important agreement strengthens reliance upon each other’s inspection expertise and resources. Mutual benefits for EU authorities and the FDA include:

  • The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
  • Prioritising inspections of medicines manufacturing sites on higher risk cases;
  • Assuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
  • Improving the ability to identify and address problems at manufacturing sites before they become a public health risk; and
  • Reducing the administrative burdens and costs facing pharmaceutical manufacturers, including smaller producers.

MRA scope

The mutual recognition will initially cover medicinal products for human use, veterinary products will be not later than July 2019.  Vaccines and plasma derived medicinal products will be covered not later than July 2022.

Details of EU MRAs

EMA press release

FDA press release

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  1. Comment by Lawrence Elson posted on

    How will this agreement be affected by Brexit?

  2. Comment by satish posted on

    Thank you for the update .

    Is it appicable only in respective territories ? For example If a manufacturing site is located in a third country and the site is already approved by MHRA . Does USFDA consider that approval ? Can that mfg site can manufacture for US market ?

    • Replies to satish>

      Comment by Mark Birse posted on

      The MRA is not only applicable to respective territories and may also cover 3rd country inspections. This is down to each Party determining its own terms and conditions under which it would accept this.

      This is covered by Article 8 (recognition of inspections), paragraphs 3 and 4 -

      3. A Party may accept official GMPs documents issued by a recognized authority of the other Party for manufacturing facilities located outside the territory of the issuing authority.

      4. Each Party may determine the terms and conditions under which it accepts official GMPs documents issued under paragraph 3.

  3. Comment by Darshan posted on

    Hi we are a MHRA approved Contract testing laboratory and we have client who want to test product which they had developed for US market.
    Can we test in our Lab ?

    • Replies to Darshan>

      Comment by Mark Birse posted on


      In general products that are imported into the USA have their release testing conducted at the point of manufacture - which may involve a contract laboratory. Concerning your case it would be for your contract giver to ensure you are registered and approved in the drug licence with FDA.

      Kind regards,


      • Replies to Mark Birse>

        Comment by Darshan posted on

        Thanks for your reply.

        Kind regards,