Working with regulators to advance access to quality medicines
The best way to ensure quality is by meeting the rigorous guidelines of stringent regulatory authorities (SRAs),1 for example, those of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Swissmedic or the World Health Organization (WHO)’s prequalification programme.
SRA approval indicates high levels of safety and efficacy
SRA approval or opinion indicates a new medicine has met the highest levels of safety and effectiveness in the specific patient populations in which it was studied. These internationally recognized approvals also enable medicines to be procured and distributed by international funding bodies, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria.
Early, proactive engagement with regulators
The SRA assessment process of a new drug application (NDA) often takes about a year. To make the process as smooth as possible, MMV engages proactively with regulators early in the drug development process. Ahead of dossier submission, we ensure compliance with the clinical data requirements and incorporate regulatory guidance into the design of our protocols and trials. This decreases the risk of the dossier failing to meet the SRA’s standard and makes the process more efficient. In addition, this collaborative relationship with regulators, as well as with our development partners, allows MMV to leverage drug development experience and know-how towards the ultimate goal of benefiting patients.
Regular, real-time feedback shortens drug development timelines
SRAs are keenly aware of the need for expedited development of drugs for neglected tropical diseases and malaria. Under the FDA's Food and Drug Administration Safety and Innovation Act,2 Breakthrough Therapy Designation and Priority Review are two of four expedited review and development mechanisms used today.3 After several consultations with the FDA, tafenoquine (the first new drug for prevention of malaria relapse in several decades) was granted both of these before being approved in 2018. The benefit of regular, real-time feedback translates to shorter drug development timelines which ultimately, for patients, means earlier access to lifesaving therapies.
EMA’s Article 58 procedure
The EMA is also engaged in activities to support approval of medicines for neglected diseases. Since 2004, in cooperation with WHO, the EMA has been undertaking regulatory assessments and providing scientific opinion on products not intended for use in Europe through the Article 58 procedure. Pyramax® (pyronaridine-artesunate), developed by MMV and Shin Poong, was the first antimalarial to be granted a positive scientific opinion by the EMA under Article 58.
MMV develops medicines to rigorous standard
MMV also works closely with partners to ensure their medicines meet the criteria for inclusion in the WHO list of prequalified medicines. We consider WHO prequalification the seal of approval for medicines already listed on the WHO treatment guidelines.
MMV’s goal is crystal clear: to develop high-quality antimalarials and ensure their timely access to vulnerable populations. By interacting with regulatory bodies at each stage of development, and meeting their rigorous standards, we are working to realize this goal for malaria patients all around the world.
- A regulatory body which is: (a) a member of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) or (b) an ICH observer, being the European Free Trade Association (EFTA), as represented by Swissmedic and Health Canada (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement currently including Australia, Iceland, Liechtenstein and Norway (http://apps.who.int/prequal/)
- The Food and Drug Administration Safety and Innovation Act, Public Law 112–144, 112th Congress (2012)
- The FDA’s Four Expedited Review Pathways for Drugs
- WHO-TDR: World Health Organization Special Programme for Research and Training in Tropical Diseases.