Priority Medicines (PRIME)

Priority Medicines (PRIME)

Poster

Gergana Dudaklieva1, Emil Hristov1, Kalina Andreevska1, Iva Parvova2
1Chemistry and Pharmacy faculty, Sofia University “St. Kliment Ohridski, Bulgaria
2Rheumatology department, Medical University Sofia, Bulgaria

Introduction: In 2016 EMA introduces and launches a new program, called Priority Medicines (PRIME). It’s targeted at improving the support for the development of medicaments aiming at unexploited medicinal needs. This will help patients make use of earliest possible therapies, that significantly contribute to their well-being. Aim: To present a legislative framework, granting access to Priority Medicines. Materials and methods: Document and content analysis were used. Results: The criteria for PRIME approval are that the medicinal products show considerable therapeutic advancements, compared to existing therapies and provide therapeutic aid to patients, that have no other treatment alternatives. CHMP can decrease the longevity of the grading process from 210 to 150 days, if the applicant provides enough reasonable justification (that the product presents a substantial interest to the common health and therapeutic innovations). The main advantages of ЕМА to the candidates chosen for prime are an appointment of a representative from CHMP or CAT, that can assist in building knowledge before applying for a usage permit; composing a multidisciplinary group of experts, whose purpose is to contribute with guidance on the overall development plan and regulatory strategy; appointing a concrete contact point with the group, that will coordinate their support during the entire program; carrying out scientific consultations on key stages and confirming the potential for an accelerated appraisal. Conclusion: The purpose of PRIME is to provide patients with promising and innovative medication as early as possible, by optimizing and supporting its development.
Keywords: medicaments, Priority Medicines, PRIME