Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Fast and Simplified Procedures for Herbal Medicinal Products in Pacific Alliance Countries

Sandra Walkowiak (Abschlußjahr: 2021)

Summary
Language: English
A fast market access of innovative medicinal products is frequently impeded by the duration of approval pro¬cesses. Due to the related costs, small and medium-sized (SME) pharmaceutical companies often hesitate to develop new products and to seek a marketing authorization (MA). In several non-European countries, additional clinical studies, are re¬qui-red even for drugs that have already been successfully approved in the European Union.
In this thesis, oppor¬tunities are iden¬tified to get a fast and simplified entry of herbal medicinal products (HMPs) into emerging markets in selec¬ted countries of Latin America without or with limited pre-clinical and clinical data. HMPs stand for gentle medi¬cation; their safety and efficacy must be either verified in well-established medi¬cinal use by scientific literature, or by a long tradition in therapeutic use.
The analysis presented is restricted to the emerging markets of Mexico, Colombia, and Peru and is based on legal texts, scientific publications, journal articles, and regulatory databases. Together with Chile these countries founded a trade block in 2012, the ‘Pacific Alliance’, as counterpart to Brasilia and Mercosur (Mercado Común del Sur), respectively. With recognition of COFEPRIS (Mexcio) and INVIMA (Columbia) as regional reference countries (rNRAs) by the Pan American/World Health Organization (PAHO/WHO) and as members of the Pan American Network for Drug Regulatory Harmonization (PANDRH) they are pursuing the common goal of harmonizing regulatory strategies and to simplify processes. This is reached by mutual GMP recognition, harmonization of guide¬lines, introduction of elec¬tro¬nic submissions, standardization of procedures, shortening of the review times, etc. Moreover, INVIMA implemented automatic procedures to increase regulatory efficiency which were extended to HMPs in 2018. This led to significantly reduced review times. Mexico is shortening their review times for different procedures as well. Lately, times of the renewals were further shortened in May 2021.
Further goals are the strengthening of the national regulatory authority (NRA) in Peru and finally those in the Americas to reach the international rNRA level (NRA level 4). Harmonization of good review praxis in the region and acceleration of the approval process will ensure the supply of patients with medicines that are safe, effective, and of high quality.
Pages: 100, Figures: 13, Tables: 33
Annexes: VII, Pages: 26