MUTUAL RECOGNITION AGREEMENTS (MRA)
Mutual Recognition Agreements (MRAs) benefit national regulators by reducing duplication of inspections in each other's country and around the world. They also allow for a greater focus on potentially higher-risk facilities and expanded inspection coverage across the global supply chain. In this way, MRAs facilitate trade in medicines, improve the supply of and access to medicines for patients through fewer inspections at manufacturing facilities and, where applicable, by eliminating the need to retest products after importation
Considering the advantages that MRAs will bring to the Turkish pharmaceutical industry and in the context of PIC/S membership, TITCK published the "Mutual Recognition Guideline on Pharmaceutical Inspection Activities" on July 9, 2019. The guideline, which sets out the Agency's views on this concept, regulates the procedures and principles regarding the MRA applications of national regulatory authorities to the TITCK regarding GMP inspections.
Although Türkiye has not yet concluded any MRAs for GMP certifications and audits, this objective is included in high-level policy documents. This issue was included in the 2021 Action Plan of the Coordination Board for Improvement of the Investment Environment (YOIKK) under the following title: "Recognition of Good Manufacturing Practices (GMP) audits and certificates in accordance with our national interests and on the basis of mutual interest, specific to the pharmaceutical groups and countries to which our exports are concentrated, by establishing Mutual Recognition Agreements (MRAs) with the member countries of the Pharmaceutical Inspection Cooperation Convention (PIC/s), of which Türkiye is also a member."
In this context and upon the request of the TITCK, AIFD forwarded to the TITCK the list of countries that would benefit from signing a MRA as "EU Member States, the United Kingdom, Switzerland, Canada, South Korea and Singapore" without any prioritization order.
Finally, we have evaluated that during further negotiations of the existing FTA with the United Kingdom will create a favorable environment for the conclusion of a MRA between the two countries covering GMP and serial release, and AIFD has prepared a joint study with our counterpart organization in the United Kingdom, the Association of the British Pharmaceutical Industry (ABPI), in which we assessed the possible benefits of signing a MRA covering GMP and serial release between our country and the UK and shared the study with the relevant Authorities.
