On 11 July 2019, the Commission released that Slovakia has been the last of the EU Member States to recognize the US Food and Drug Administration (FDA) and therefore, the Mutual Recognition Agreement of inspections of medicines manufacturers between the European Union and the United States has been fully implemented. This agreement is significant since it allows a mutual recognition for inspections on pharmaceutical products in USA and EU and it reduces the barriers on trade between the countries.
The similar kind of agreement drafted in 1998 had never been fully implemented due to the lack of authorizations. A new try for the mutual recognition emerged in 2017, when President Juncker and Trump concluded a Joint Statement to develop cooperation on pharmaceutical trade. Antecedently, EU has implemented the same Mutual Recognition Agreement with Australia, Canada, Israel, Japan, New Zealand and Switzerland.
The corollary changes by the Mutual Recognition Agreement in the trade of pharmaceuticals are significant. The enhanced cooperation with European Medicine Agency (EMA) and the U.S. Food and Drug Administration (FDA) will allow an equivalent recognition of inspections on the Good Manufacturing Practice For instance, this means that the European pharmaceutical providers seeking for expansion of their business in USA need no longer to have inspections on the products in USA if EMA has already recognized the product. Also, the EMA can rely on the results of inspection from the FDA.
The qualified persons in the EU pharmaceutical company will be relieved of their task for carrying out the quality controls when carried out already in the United States.
The agreement has also an effect to the administrative inspections of the pharmaceutic products. It facilitates the exchange of information between EMA and FDA. Moreover, both of the authorities are entitled to supervise the manufacturing practice (concerning the manufacture, processing, packing, release and holding of a medicine) of the products in their respective territories at any time. The agreement is also applicable for the products manufactured in third countries and inspected by the authority of USA or EU.
Products included in the applicable scope
The products covered by the Agreement are marketed, finished pharmaceuticals for human use in carious pharmaceutical dosage forms such as tablets, capsules, ointments, and injectables. Furthermore, marketed biological products, intermediate products, active pharmaceutical ingredient or bulk drug substances are also included in the list. Although the veterinary products are not yet qualified in the Mutual Recognition Agreement, they will be included no later than 15th of December 2019. Human blood, plasma, tissues and organs, and veterinary immunologicals are excluded from the Agreement.
The EU and the US are willing to continue the implementation for the Mutual Recognition Agreement in order to extend the applicable scope to a wider range of products.
Impact of the MRA
The purpose of the Mutual Recognition Agreement is to benefit public health and to facilitate the trade. The MRA is a milestone to abrogate the duplication of inspections and thus reveal the responsibilities of trading. The companies are likely to benefit from the Agreement, since the process on expanding the trade of pharmaceutical products will be less complex. The Agreement certainly improves and will likely improve the efficiency between these two regulatory systems, which can be a great advantage for the manufacturers.
The Mutual Recognition Agreement will substantially improve the trade between both regions and boost the pharmaceutical industry, with great benefit to both manufacturers and distributors. In particular, internationally active European and Spanish companies operating or willing to operate in USA (or vice versa, US companies willing to operate in the EU or in Spain) may benefit from relaxation of procedures, without compromising quality and safety of their products.
In Lleytons we specialize in Pharmaceutical and Cosmetic Law by providing the legal advice necessary for ensuring the respect of current regulations and guaranteeing manufacturer or distributors’ rights under the existing laws.