Special Issue “Regulatory and Technological Aspects of New Drugs for Old Active Pharmaceutical Ingredients”

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Special Issue “Regulatory and Technological Aspects of New Drugs for Old Active Pharmaceutical Ingredients”



Paola Minghetti, Umberto M. Musazzi, Paolo Rocco.





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The regulatory framework governing the development, production, and marketing of new medicinal products is continuously evolving as a consequence of scientific and technological progress. Its aim is to ensure citizens’ health by establishing provisions that pharmaceutical stakeholders must follow to assure the quality, efficacy, and safety of the medicines they place on the market.

For new medicinal products containing old drug substances, the technological development and the regulatory pathways differ, based on the intention-to-treat of the drug product, e.g., improvement of the therapeutic value of an existing treatment, drug repositioning, or marketing of a therapeutically equivalent copy. Based on product-specific features, regulatory authorities may allow a simplification in the authorization procedure and/or in the nature and extent of the data to be submitted based on the product’s innovativeness, the context in which it has to be authorized (e.g., orphan drugs), and the availability of information from therapeutically equivalent authorized medicaments. However, numerous regulatory and economic barriers still hinder patient access to pharmacological therapies, especially in cases where medicine production is not economically sustainable. Moreover, several technological gaps hinder the reliability of in vitro/in vivo studies performed during the pharmaceutical development of novel medicinal products and assessment of their biorelevance.

In this light, this Special Issue aims to stimulate discussion around possible solutions for rationalizing the regulatory framework and current technological development for promoting the establishment of more reliable methods to develop and assess the quality, safety, and efficacy of new/innovative medicinal products containing old drug substances.