News Category: Regulatory news
The EU and US authorities signed a mutual recognition agreement (MRA) that entered into force on 1 November 2017 with a transition phase for recognition of EU Member States until July 2019. The MRA contains a sectoral annex on the mutual recognition of pharmaceutical good manufacturing practice (GMP).
The US FDA concluded its capability assessment of the HPRA and confirmed that it has the capability, capacity and procedures to carry out GMP inspections at an equivalent level. Consequently, Ireland has been included on the list of recognised member states on 1 June 2018.
The MRA comes as a result of assessments of both the EU national competent authorities’ (NCAs) and US FDA’s inspection systems. In June 2017, the European Commission confirmed that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. An audit of the HPRA’s GMP inspection system, under the joint audit programme (JAP), took place from 15 to 19 May 2017 and was observed by FDA investigators.
Scope of the MRA
The initial scope includes: human medicines, which incorporates intermediates and in-process materials, biologicals, including immunologicals and biotherapeutic products, and active pharmaceutical ingredients (APIs).
Vaccines for human use and plasma derived medicines, are excluded at this time but a decision will be made no later than July 2022.
Veterinary medicines are excluded at this time but a decision on their inclusion will be made no later than July 2019.
The following products are excluded:
- human blood and plasma;
- human tissues and organs;
- veterinary immunologicals;
- advanced therapy medicinal products.
Full details of the scope of products included in the EU-US MRA can be found on the European Medicines Agency's website. The EMA has also published a Questions and Answers document on the impact of the agreement.
What does this mean for pharmaceutical manufacturers located in Ireland and the US?
As a direct result of Ireland being included on the list, the US FDA can now rely on HPRA inspections to replace their own inspections. This should result in the following:
- Reduced number of FDA inspections of manufacturers located in Ireland;
- Reduced number of HPRA inspections of US manufacturers;
- Improved efficiency of assessments involving contract manufacturing sites based in the US;
- Increased inspection resources available to inspect in other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.
Although the intent of the MRA is to rely on the factual findings in official GMP documents shared between inspectorates, the MRA does permit circumstances where EU national competent authorities or US FDA can conduct their own inspections in each other’s territory.